The following data is part of a premarket notification filed by Hill-rom, Inc. with the FDA for Flexicair Exlipse.
Device ID | K951001 |
510k Number | K951001 |
Device Name: | FLEXICAIR EXLIPSE |
Classification | Bed, Flotation Therapy, Powered |
Applicant | HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
Contact | Edwin Bills |
Correspondent | Edwin Bills HILL-ROM, INC. 4349 CORPORATE RD. Charleston, SC 29405 |
Product Code | IOQ |
CFR Regulation Number | 890.5170 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-03-03 |
Decision Date | 1995-06-27 |