The following data is part of a premarket notification filed by Datex-ohmeda with the FDA for Datex-ohmeda S/5tm Fm With L-ficu04 And L-ficu04a Software And N-fcrec Module.
| Device ID | K043276 |
| 510k Number | K043276 |
| Device Name: | DATEX-OHMEDA S/5TM FM WITH L-FICU04 AND L-FICU04A SOFTWARE AND N-FCREC MODULE |
| Classification | Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) |
| Applicant | DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | MHX |
| CFR Regulation Number | 870.1025 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-26 |
| Decision Date | 2004-12-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682120111 | K043276 | 000 |