510(k) K950331
K950331 is an FDA 510(k) premarket notification submitted by Healthdyne, Inc. for the device "PRESSURE SUPPORT VENTILATORY ASSIST SYSTEM (PSVAS)". The FDA issued a decision of Substantially Equivalent on September 21, 1995. The device falls under product code BZD (Ventilator, Non-Continuous (Respirator)), a Class II device regulated under 21 CFR 868.5905. Healthdyne, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 21, 1995
- Date Received
- January 27, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ventilator, Non-Continuous (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5905
- Review Panel
- AN
- Submission Type