The following data is part of a premarket notification filed by Huntleigh Technology, Inc. with the FDA for Dopcord Ppg.
Device ID | K884451 |
510k Number | K884451 |
Device Name: | DOPCORD PPG |
Classification | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic |
Applicant | HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Contact | Tim Justice |
Correspondent | Tim Justice HUNTLEIGH TECHNOLOGY, INC. 227 ROUTE 33 EAST Manalapan, NJ 07726 |
Product Code | JOM |
CFR Regulation Number | 870.2780 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1988-10-24 |
Decision Date | 1989-01-12 |