510(k) K813602
K813602 is an FDA 510(k) premarket notification submitted by Applied Cardiac Systems for the device "HOLTER PERFORMER". The FDA issued a decision of Substantially Equivalent on January 29, 1982. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Applied Cardiac Systems has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1982
- Date Received
- December 28, 1981
- 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