The following data is part of a premarket notification filed by Medsys, Inc. with the FDA for Capnoxygen Mask.
| Device ID | K971229 |
| 510k Number | K971229 |
| Device Name: | CAPNOXYGEN MASK |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | MEDSYS, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Contact | George Myers |
| Correspondent | George Myers MEDSYS, INC. 377 ROUTE 17 SOUTH Hasbrouck Heights, NJ 07604 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-04-02 |
| Decision Date | 1997-09-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10620974001871 | K971229 | 000 |
| 10620974001529 | K971229 | 000 |
| 10620974001499 | K971229 | 000 |
| 10620974001482 | K971229 | 000 |
| 10620974001475 | K971229 | 000 |