The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Keymed Sigmoidoscope Suction Unit.
| Device ID | K841822 |
| 510k Number | K841822 |
| Device Name: | KEYMED SIGMOIDOSCOPE SUCTION UNIT |
| Classification | Compressor, Cardiac, External |
| Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | DRM |
| CFR Regulation Number | 870.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-02 |
| Decision Date | 1984-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 15019778005386 | K841822 | 000 |
| 15019778005140 | K841822 | 000 |