510(k) K904992
K904992 is an FDA 510(k) premarket notification submitted by Minntech Corp. for the device "MINNILERT AIR DETECTOR". The FDA issued a decision of Substantially Equivalent on February 5, 1991. The device falls under product code FJF (Detector, Air Bubble), a Class II device regulated under 21 CFR 876.5820. Minntech Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 5, 1991
- Date Received
- November 7, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Detector, Air Bubble
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type