510(k) K760076
K760076 is an FDA 510(k) premarket notification submitted by Fraser Sweatman, Inc. for the device "ABSORBER, ANESTHESIA CIRCLE SYS, CO2". The FDA issued a decision of Substantially Equivalent on July 16, 1976. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310. Fraser Sweatman, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 16, 1976
- Date Received
- June 18, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Absorber, Carbon-Dioxide
- Device Class
- Class I
- Regulation Number
- 868.5310
- Review Panel
- AN
- Submission Type