510(k) K923233
K923233 is an FDA 510(k) premarket notification submitted by Cardio-Med-Associates, Inc. for the device "CARDIO-PAK LAPAROTOMY PACK". The FDA issued a decision of Substantially Equivalent (kit) on March 20, 1993. The device falls under product code FZH (Apparatus, Air Handling, Room), a Class II device regulated under 21 CFR 878.5070. Cardio-Med-Associates, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- March 20, 1993
- Date Received
- July 1, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Air Handling, Room
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- SU
- Submission Type