510(k) K874571
K874571 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology, Inc. for the device "PATIENTWATCH (TM)". The FDA issued a decision of Substantially Equivalent on Jan 29, 1988. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Advanced Medical Technology, Inc. has 7 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 29, 1988
- Date Received
- Nov 5, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Recorder, Magnetic Tape, Medical
- Device Class
- Class II
- Regulation Number
- 870.2800
- Review Panel
- CV
- Submission Type
- 510(k)