510(k) K944949
K944949 is an FDA 510(k) premarket notification submitted by Vital Signs, Inc. for the device "GENERAL ANESTHESIA SYSTEM". The FDA issued a decision of Substantially Equivalent (kit) on November 14, 1994. The device falls under product code BTK (Strap, Head, Gas Mask), a Class I device regulated under 21 CFR 868.5560. Vital Signs, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- November 14, 1994
- Date Received
- October 7, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Strap, Head, Gas Mask
- Device Class
- Class I
- Regulation Number
- 868.5560
- Review Panel
- AN
- Submission Type