The following data is part of a premarket notification filed by Instromedix, Inc. with the FDA for Compressar Disposable Disc.
| Device ID | K831337 |
| 510k Number | K831337 |
| Device Name: | COMPRESSAR DISPOSABLE DISC |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | INSTROMEDIX, INC. MD |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-04-25 |
| Decision Date | 1983-07-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10815614020187 | K831337 | 000 |