The following data is part of a premarket notification filed by Sensormedics Corp. with the FDA for Sensormedics Microgard Microbial Filter.
| Device ID | K934272 |
| 510k Number | K934272 |
| Device Name: | SENSORMEDICS MICROGARD MICROBIAL FILTER |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Contact | David M Trueblood |
| Correspondent | David M Trueblood SENSORMEDICS CORP. 22705 SAVI RANCH PKWY. Yorba Linda, CA 92887 -4645 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-08-31 |
| Decision Date | 1993-11-24 |