The following data is part of a premarket notification filed by Fenem, Inc. with the FDA for 2nd Modification Of Fef(tm) End-tidal Co2 Detector.
| Device ID | K894053 |
| 510k Number | K894053 |
| Device Name: | 2ND MODIFICATION OF FEF(TM) END-TIDAL CO2 DETECTOR |
| Classification | Analyzer, Gas, Carbon-dioxide, Gaseous-phase |
| Applicant | FENEM, INC. 84 WILLIAM ST. 16TH FLOOR New York, NY 10038 |
| Contact | Sheila Glennon |
| Correspondent | Sheila Glennon FENEM, INC. 84 WILLIAM ST. 16TH FLOOR New York, NY 10038 |
| Product Code | CCK |
| CFR Regulation Number | 868.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-06-07 |
| Decision Date | 1989-07-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884521084046 | K894053 | 000 |
| 30884521084036 | K894053 | 000 |
| 10884521709829 | K894053 | 000 |