The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Beta Ii Hm85.
Device ID | K870681 |
510k Number | K870681 |
Device Name: | HUNTLEIGH BETA II HM85 |
Classification | Mattress, Air Flotation, Alternating Pressure |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Contact | James Britton |
Correspondent | James Britton HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Product Code | FNM |
CFR Regulation Number | 880.5550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-19 |
Decision Date | 1987-03-04 |