The following data is part of a premarket notification filed by Dj Medical Instrument Corp. C/o Keller & Heckman with the FDA for Ha-2 Human Body Composition Analyzer.
Device ID | K860749 |
510k Number | K860749 |
Device Name: | HA-2 HUMAN BODY COMPOSITION ANALYZER |
Classification | Plethysmograph, Impedance |
Applicant | DJ MEDICAL INSTRUMENT CORP. C/O KELLER & HECKMAN 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
Contact | John B Dubeck |
Correspondent | John B Dubeck DJ MEDICAL INSTRUMENT CORP. C/O KELLER & HECKMAN 1150 17TH STREET, N.W. SUITE 1000 Washington, DC 20036 |
Product Code | DSB |
CFR Regulation Number | 870.2770 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-27 |
Decision Date | 1986-09-02 |