The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Huntleigh Flowpac Fp2000.
Device ID | K871272 |
510k Number | K871272 |
Device Name: | HUNTLEIGH FLOWPAC FP2000 |
Classification | Compressor, Cardiac, External |
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 | DRM |
CFR Regulation Number | 870.5200 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-03-31 |
Decision Date | 1987-06-25 |