510(k) K862776
K862776 is an FDA 510(k) premarket notification submitted by Cardionics, Inc. for the device "SPECTRUM POLYCORD I RECORDER SYSTEM". The FDA issued a decision of Substantially Equivalent on Aug 18, 1986. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Cardionics, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 18, 1986
- Date Received
- Jul 22, 1986
- 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)