510(k) K963633
K963633 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "VENTNET; CENTRAL MONITORING STATION". The FDA issued a decision of Substantially Equivalent on December 16, 1996. The device falls under product code MOD (Accessory To Continuous Ventilator (Respirator)), a Class II device regulated under 21 CFR 868.5895. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 1996
- Date Received
- September 11, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessory To Continuous Ventilator (Respirator)
- Device Class
- Class II
- Regulation Number
- 868.5895
- Review Panel
- AN
- Submission Type