510(k) K864852
K864852 is an FDA 510(k) premarket notification submitted by Vacumetrics, Inc. for the device "VISTA INTERFACE SYSTEM". The FDA issued a decision of Substantially Equivalent on March 4, 1987. The device falls under product code BZL (Computer, Oxygen-Uptake), a Class II device regulated under 21 CFR 868.1730. Vacumetrics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 4, 1987
- Date Received
- December 11, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Computer, Oxygen-Uptake
- Device Class
- Class II
- Regulation Number
- 868.1730
- Review Panel
- AN
- Submission Type