The following data is part of a premarket notification filed by Maquet, Inc. with the FDA for Servo Guard, Model 64 81 290 Eh88e.
| Device ID | K030071 |
| 510k Number | K030071 |
| Device Name: | SERVO GUARD, MODEL 64 81 290 EH88E |
| Classification | Filter, Bacterial, Breathing-circuit |
| Applicant | MAQUET, INC. 1140 ROUTE 22 EAST SUITE 202 Bridgewater, NJ 08807 |
| Contact | Jamie Yieh |
| Correspondent | Jamie Yieh MAQUET, INC. 1140 ROUTE 22 EAST SUITE 202 Bridgewater, NJ 08807 |
| Product Code | CAH |
| CFR Regulation Number | 868.5260 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-08 |
| Decision Date | 2004-04-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 17325710004576 | K030071 | 000 |
| 17325710004569 | K030071 | 000 |