The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Alphacare, Hm95 Alternating Press-pump.
Device ID | K844879 |
510k Number | K844879 |
Device Name: | HUNTLEIGH ALPHACARE, HM95 ALTERNATING PRESS-PUMP |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 103-1A CHURCH ST. Aberdeen, NJ 07747 |
Contact | James Britton |
Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 103-1A CHURCH ST. Aberdeen, NJ 07747 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-12-17 |
Decision Date | 1985-01-25 |