The following data is part of a premarket notification filed by Medical Flotation Systems, Inc. with the FDA for Ultraflotation Bed.
Device ID | K882607 |
510k Number | K882607 |
Device Name: | ULTRAFLOTATION BED |
Classification | Bed, Flotation Therapy, Powered |
Applicant | MEDICAL FLOTATION SYSTEMS, INC. 104 ELDEN ST., SUITE 11 Herndon, VA 22070 |
Contact | Jacobs, Md |
Correspondent | Jacobs, Md MEDICAL FLOTATION SYSTEMS, INC. 104 ELDEN ST., SUITE 11 Herndon, VA 22070 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-06-24 |
Decision Date | 1988-10-14 |