510(k) K772320
K772320 is an FDA 510(k) premarket notification submitted by Physio-Control Corp. for the device "EMERGENCY CART". The FDA issued a decision of Substantially Equivalent on January 3, 1978. The device falls under product code BZN (Cart, Emergency, Cardiopulmonary (Excluding Equipment)), a Class I device regulated under 21 CFR 868.6175. Physio-Control Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1978
- Date Received
- December 19, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cart, Emergency, Cardiopulmonary (Excluding Equipment)
- Device Class
- Class I
- Regulation Number
- 868.6175
- Review Panel
- AN
- Submission Type