The following data is part of a premarket notification filed by Cobe Laboratories, Inc. with the FDA for Cobe Disposable Pressure Transducer.
| Device ID | K810637 |
| 510k Number | K810637 |
| Device Name: | COBE DISPOSABLE PRESSURE TRANSDUCER |
| Classification | Transducer, Blood-pressure, Extravascular |
| Applicant | COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Contact | None None |
| Correspondent | None None COBE LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRS |
| CFR Regulation Number | 870.2850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-03-10 |
| Decision Date | 1981-04-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450332815 | K810637 | 000 |
| 10884450332679 | K810637 | 000 |
| 10884450332402 | K810637 | 000 |
| 10884450332419 | K810637 | 000 |
| 10884450332372 | K810637 | 000 |
| 10884450332990 | K810637 | 000 |
| 10884450332488 | K810637 | 000 |
| 00884450332825 | K810637 | 000 |