510(k) K924341
K924341 is an FDA 510(k) premarket notification submitted by Respironics, Inc. for the device "HAYEK OSCILLATOR(TM)". The FDA issued a decision of Substantially Equivalent on July 21, 1993. The device falls under product code BYT (Ventilator, External Body, Negative Pressure, Adult (Cuirass)), a Class II device regulated under 21 CFR 868.5935. Respironics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 21, 1993
- Date Received
- August 27, 1992
- 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