The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Trutrak Plus Enhancements To The Datex-ohmeda 3800 Series & 3900 Series Oximeters & Accessories.
| Device ID | K021955 |
| 510k Number | K021955 |
| Device Name: | TRUTRAK PLUS ENHANCEMENTS TO THE DATEX-OHMEDA 3800 SERIES & 3900 SERIES OXIMETERS & ACCESSORIES |
| Classification | Oximeter |
| Applicant | DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Contact | Michael A Chilbert |
| Correspondent | Michael A Chilbert DATEX-OHMEDA, INC. 1315 WEST CENTURY DR. Louisville, CO 80027 |
| Product Code | DQA |
| CFR Regulation Number | 870.2700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-14 |
| Decision Date | 2002-10-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682103367 | K021955 | 000 |
| 00840682103343 | K021955 | 000 |
| 00840682103169 | K021955 | 000 |