510(k) K863300
K863300 is an FDA 510(k) premarket notification submitted by Quinton, Inc. for the device "Q101 DIAGNOSTIC SPIROMETER". The FDA issued a decision of Substantially Equivalent on November 13, 1986. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Quinton, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 13, 1986
- Date Received
- August 25, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, External Body, Negative Pressure, Adult (Cuirass)
- Device Class
- Class II
- Regulation Number
- 868.5935
- Review Panel
- AN
- Submission Type