The following data is part of a premarket notification filed by Cp Bio-medical Corp. with the FDA for Patpos Compact.
Device ID | K930295 |
510k Number | K930295 |
Device Name: | PATPOS COMPACT |
Classification | Monitor, Patient Position, Light-beam |
Applicant | CP BIO-MEDICAL CORP. 153 E.PALMETTO PARK RD. SUITE 133 Boca Raton, FL 33432 |
Contact | Van Arkel |
Correspondent | Van Arkel CP BIO-MEDICAL CORP. 153 E.PALMETTO PARK RD. SUITE 133 Boca Raton, FL 33432 |
Product Code | IWE |
CFR Regulation Number | 892.5780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-01-21 |
Decision Date | 1993-05-21 |