510(k) K863172
K863172 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "RESPIRONICS PTL REVIVEEASY". The FDA issued a decision of Substantially Equivalent on November 4, 1986. The device falls under product code CAO (Airway, Esophageal (Obturator)), a Class II device regulated under 21 CFR 868.5650. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 4, 1986
- Date Received
- August 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Airway, Esophageal (Obturator)
- Device Class
- Class II
- Regulation Number
- 868.5650
- Review Panel
- AN
- Submission Type