The following data is part of a premarket notification filed by Pedicraft, Inc. with the FDA for Pedicraft Bed, Model B2944.
Device ID | K821773 |
510k Number | K821773 |
Device Name: | PEDICRAFT BED, MODEL B2944 |
Classification | Bed, Pediatric Open Hospital |
Applicant | PEDICRAFT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FMS |
CFR Regulation Number | 880.5140 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1982-06-16 |
Decision Date | 1982-06-23 |