510(k) K761210
K761210 is an FDA 510(k) premarket notification submitted by Physio-Control Corp. for the device "LIMB LEAD SEL. (ECG LEAD SWITCHING AD.)". The FDA issued a decision of Substantially Equivalent on December 21, 1976. The device falls under product code DRW (Adaptor, Lead Switching, Electrocardiograph), a Class II device regulated under 21 CFR 870.2350. Physio-Control Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 21, 1976
- Date Received
- December 7, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Adaptor, Lead Switching, Electrocardiograph
- Device Class
- Class II
- Regulation Number
- 870.2350
- Review Panel
- CV
- Submission Type