The following data is part of a premarket notification filed by Edgewater Medical Equipment Systems with the FDA for The Portable Orderly.
Device ID | K872900 |
510k Number | K872900 |
Device Name: | THE PORTABLE ORDERLY |
Classification | Operating Room Accessories Table Tray |
Applicant | EDGEWATER MEDICAL EQUIPMENT SYSTEMS 6263 MAYFIELD RD. SUITE 206 Mayfield Hts., OH 44124 |
Contact | Daniel Allen |
Correspondent | Daniel Allen EDGEWATER MEDICAL EQUIPMENT SYSTEMS 6263 MAYFIELD RD. SUITE 206 Mayfield Hts., OH 44124 |
Product Code | FWZ |
CFR Regulation Number | 878.4950 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-07-24 |
Decision Date | 1987-08-21 |