The following data is part of a premarket notification filed by Keymed, Inc. with the FDA for Keymed Mobile Endoscopy Patient Couch.
Device ID | K840920 |
510k Number | K840920 |
Device Name: | KEYMED MOBILE ENDOSCOPY PATIENT COUCH |
Classification | Stretcher, Wheeled |
Applicant | KEYMED, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FPO |
CFR Regulation Number | 880.6910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-03-01 |
Decision Date | 1984-03-19 |