510(k) K022540
K022540 is an FDA 510(k) premarket notification submitted by Rozinn Electronics, Inc. for the device "CARDIO ID+(RZ153+)". The FDA issued a decision of Substantially Equivalent on October 24, 2002. The device falls under product code DSH (Recorder, Magnetic Tape, Medical), a Class II device regulated under 21 CFR 870.2800. Rozinn Electronics, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 24, 2002
- Date Received
- August 1, 2002
- 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