510(k) K910170
K910170 is an FDA 510(k) premarket notification submitted by Adler Instrument Co. for the device "MAXI-FLOW SUCTION SET 12 FT.". The FDA issued a decision of Substantially Equivalent on February 1, 1991. The device falls under product code GAZ (Tubing, Noninvasive), a Class II device regulated under 21 CFR 880.6740. Adler Instrument Co. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 1, 1991
- Date Received
- January 15, 1991
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tubing, Noninvasive
- Device Class
- Class II
- Regulation Number
- 880.6740
- Review Panel
- HO
- Submission Type