510(k) K790185
K790185 is an FDA 510(k) premarket notification submitted by Electronics For Medicine, Inc. for the device "MODEL V 4207 INTEGRATING PLUG-IN". The FDA issued a decision of Substantially Equivalent on Feb 16, 1979. The device falls under product code BZC (Calculator, Pulmonary Function Data), a Class II device regulated under 21 CFR 868.1880. Electronics For Medicine, Inc. has 8 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 16, 1979
- Date Received
- Jan 29, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Calculator, Pulmonary Function Data
- Device Class
- Class II
- Regulation Number
- 868.1880
- Review Panel
- AN
- Submission Type
- 510(k)