510(k) K863171
K863171 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "RESPIRONICS PROTECTEASY". The FDA issued a decision of Substantially Equivalent on October 15, 1986. The device falls under product code KGK (Gas, Collecting Vessel), a Class I device regulated under 21 CFR 868.1575. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 15, 1986
- Date Received
- August 18, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas, Collecting Vessel
- Device Class
- Class I
- Regulation Number
- 868.1575
- Review Panel
- AN
- Submission Type