The following data is part of a premarket notification filed by Air Med Assist Products with the FDA for Nurse's Aid Patient Rotation System.
Device ID | K973624 |
510k Number | K973624 |
Device Name: | NURSE'S AID PATIENT ROTATION SYSTEM |
Classification | Bed, Flotation Therapy, Powered |
Applicant | AIR MED ASSIST PRODUCTS P.O. BOX 154 (FEDERAL BLDG.) 65 N. MAIN, STE Toole, UT 84074 -0154 |
Contact | John E Lincoln |
Correspondent | John E Lincoln AIR MED ASSIST PRODUCTS P.O. BOX 154 (FEDERAL BLDG.) 65 N. MAIN, STE Toole, UT 84074 -0154 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-09-23 |
Decision Date | 1998-01-21 |
Summary: | summary |