510(k) K760766
K760766 is an FDA 510(k) premarket notification submitted by Fraser Sweatman, Inc. for the device "PRE-SET 50/50 NITROUS OXIDE/OXYGEN MIXER". The FDA issued a decision of Substantially Equivalent on October 8, 1976. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Fraser Sweatman, Inc. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 8, 1976
- Date Received
- October 4, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Breathing Gases, Anesthesia Inhalation
- Device Class
- Class II
- Regulation Number
- 868.5330
- Review Panel
- AN
- Submission Type