510(k) K760402
K760402 is an FDA 510(k) premarket notification submitted by Omp Laboratories, Inc. for the device "SYRINGE SET, 3-WAY THERMODILUTIN". The FDA issued a decision of Substantially Equivalent on August 23, 1976. The device falls under product code DQO (Catheter, Intravascular, Diagnostic), a Class II device regulated under 21 CFR 870.1200. Omp Laboratories, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1976
- Date Received
- August 6, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Intravascular, Diagnostic
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type