The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Westmed, Inc.'s Blockaide Filter [21 Cfr 807.87(a)].
| Device ID | K121382 |
| 510k Number | K121382 |
| Device Name: | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | Westmed, Inc. 5580 S. NOGALES HIGHWAY Tucson, AZ 85706 |
| Contact | R. John Mckinnon |
| Correspondent | R. John Mckinnon Westmed, Inc. 5580 S. NOGALES HIGHWAY Tucson, AZ 85706 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-08 |
| Decision Date | 2012-12-06 |
| Summary: | summary |