The following data is part of a premarket notification filed by Datex Engstrom Ab with the FDA for Engstrom Hmef 1000.
| Device ID | K964204 |
| 510k Number | K964204 |
| Device Name: | ENGSTROM HMEF 1000 |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | DATEX ENGSTROM AB 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Contact | Paul E Dryden |
| Correspondent | Paul E Dryden DATEX ENGSTROM AB 6329 W. WATERVIEW CT. Mccordsville, IN 46055 -9501 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-08-29 |
| Decision Date | 1996-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483602529 | K964204 | 000 |
| 20889483601560 | K964204 | 000 |
| 20889483590581 | K964204 | 000 |
| 10889483586686 | K964204 | 000 |
| 10889483586662 | K964204 | 000 |
| 10889483586655 | K964204 | 000 |
| 10889483586624 | K964204 | 000 |
| 10889483586549 | K964204 | 000 |