KVANT and FDA - we can now export to USA direct

[Pelikan]

Happy New Year to everyone!

Just before Christmas KVANT was officially granted with FDA approval and variance number for 2013 and so from now on we can sell to USA direct.

[dsli_jon]

Indeed.. http://www.regulations.gov/#!searchR...p=true;ns=true..

However, a 'word of caution' / advice to US-buyers.. This does NOT MEAN, that this is a 'rubber-stamp' for all-other Kv's that already may-be in the US.. They can ONLY be considered 'Varianced', if, a) they are explicitly-named in the Var-approval letter, found on the site, above, and b) If they DO-contain all the features, so-herein-listed / approved...

...ie: If, for example, GK Photonics (the US Importer of Record..) spec'd / got approved that 'all US models of Kvant 'XYZ' will-have a 1- hard-beam shutter, 2- emission-indicator, 3- emission-delay circuit, 4- manual-reset-on-interlock-fault circuit, etc, etc - Guess what - if your box does NOT have those approved-features, even-IF your box is listed? Yer rig ain't compliant / is not 'covered' by the Variance... 'So what'? Well, let's say, for example, that you actually *get inspected*, by a CDRH EOS - and, it's on very-good authority that we very-likely may start seeing actual-inspections, by the CDRH, in the near-future, again - you could get written-up / in-line for a fine, even-if your box is 'on the list' of "approved" pj's, in those docs..

That-said, much of what would be needed to do, to 'get compliant', would not be much werk / too-much trouble, for any 1/2-astute builder / show-producer.. (..International Pro-DJs need-not apply.. jk...

This is NOT 'fearmongering', etc, just an fyi / fwiw / word to the wise, etc, that this "approval" is NOT a 'rubber stamp' for any / all Kv's in this land.. Use this info as you will...

ciao
j