510(k) K801148
K801148 is an FDA 510(k) premarket notification submitted by Therapac, Inc. for the device "HEMOGASTAT". The FDA issued a decision of Substantially Equivalent on June 9, 1980. The device falls under product code JRR (Regulator, Temperature), a Class I device regulated under 21 CFR 862.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 9, 1980
- Date Received
- May 13, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Regulator, Temperature
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type