The following data is part of a premarket notification filed by Inspired Technologies, Inc. with the FDA for Model 350g Gas Conserver.
Device ID | K090421 |
510k Number | K090421 |
Device Name: | MODEL 350G GAS CONSERVER |
Classification | Conserver, Oxygen |
Applicant | INSPIRED TECHNOLOGIES, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
Contact | Paul Dryden |
Correspondent | Paul Dryden INSPIRED TECHNOLOGIES, INC. 24301 WOODSAGE DRIVE Bonita Springs, FL 34134 -2958 |
Product Code | NFB |
CFR Regulation Number | 868.5905 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-02-18 |
Decision Date | 2009-05-29 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00814470020075 | K090421 | 000 |