510(k) K760017
K760017 is an FDA 510(k) premarket notification submitted by Mckesson Corp. for the device "CONSIOUS SEDATION (ANALOR P-76)". The FDA issued a decision of Substantially Equivalent on July 20, 1976. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Mckesson Corp. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1976
- Date Received
- June 11, 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