The following data is part of a premarket notification filed by Midmark Corp. with the FDA for Model 500 Pediatric Stretcher/crib.
Device ID | K852422 |
510k Number | K852422 |
Device Name: | MODEL 500 PEDIATRIC STRETCHER/CRIB |
Classification | Bed, Pediatric Open Hospital |
Applicant | MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Contact | Gene Harshbarger |
Correspondent | Gene Harshbarger MIDMARK CORP. 60 VISTA DR. P.O. BOX 286 Versailles, OH 45380 |
Product Code | FMS |
CFR Regulation Number | 880.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-06-07 |
Decision Date | 1985-07-05 |