The following data is part of a premarket notification filed by Sanitas, Inc. with the FDA for Family Healthware.
Device ID | K132173 |
510k Number | K132173 |
Device Name: | FAMILY HEALTHWARE |
Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
Applicant | SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego, CA 92027 |
Contact | Alan Donald |
Correspondent | Alan Donald SANITAS, INC. 11440 W. BERNARDO COURT, STE 300 San Diego, CA 92027 |
Product Code | DRG |
CFR Regulation Number | 870.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2013-07-15 |
Decision Date | 2014-05-30 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860508000304 | K132173 | 000 |