The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Model 561 C-arm Procedures Stretcher.
Device ID | K923730 |
510k Number | K923730 |
Device Name: | MODEL 561 C-ARM PROCEDURES STRETCHER |
Classification | Stretcher, Wheeled |
Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Contact | Bradley K Seiden |
Correspondent | Bradley K Seiden MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Product Code | FPO |
CFR Regulation Number | 880.6910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-07-27 |
Decision Date | 1994-02-09 |