510(k) K883833
K883833 is an FDA 510(k) premarket notification submitted by Matrix Medica, Inc. for the device "NITRONOX(R), FIRST RESPONSE NITRONOX(TM)". The FDA issued a decision of Substantially Equivalent on February 17, 1989. The device falls under product code BZR (Mixer, Breathing Gases, Anesthesia Inhalation), a Class II device regulated under 21 CFR 868.5330. Matrix Medica, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 17, 1989
- Date Received
- September 9, 1988
- 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