510(k) K992503
K992503 is an FDA 510(k) premarket notification submitted by Sechrist Industries, Inc. for the device "SECHRIST AIR-OXYGEN MIXER, 3500/3500HL SERIES". The FDA issued a decision of Substantially Equivalent on August 10, 1999. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Sechrist Industries, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 10, 1999
- Date Received
- July 27, 1999
- Clearance Type
- Special
- 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