The following data is part of a premarket notification filed by Advanced Medical Technology, Inc. with the FDA for Patientwatch (tm).
Device ID | K874571 |
510k Number | K874571 |
Device Name: | PATIENTWATCH (TM) |
Classification | Recorder, Magnetic Tape, Medical |
Applicant | ADVANCED MEDICAL TECHNOLOGY, INC. C/O BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553 |
Contact | David W Schlerf |
Correspondent | David W Schlerf ADVANCED MEDICAL TECHNOLOGY, INC. C/O BUCKMAN COMPANY, INC. 921 CALLE VERDE Martinez, CA 94553 |
Product Code | DSH |
CFR Regulation Number | 870.2800 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-11-05 |
Decision Date | 1988-01-29 |