The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Min-filter/s, Uni-filter Junior, Uni-filter/s Angled And Uni-filter.
| Device ID | K043120 |
| 510k Number | K043120 |
| Device Name: | MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | DATEX-OHMEDA, INC. 86 PILGRIM RD. Needham, MA 02492 |
| Contact | Joel Kent |
| Correspondent | Joel Kent DATEX-OHMEDA, INC. 86 PILGRIM RD. Needham, MA 02492 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-12 |
| Decision Date | 2005-03-01 |
| Summary: | summary |