510(k) K882547
K882547 is an FDA 510(k) premarket notification submitted by Eureka AB for the device "VARITEST". The FDA issued a decision of Substantially Equivalent on Nov 3, 1988. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 3, 1988
- Date Received
- Jun 21, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device Class
- Class II
- Regulation Number
- 870.2780
- Review Panel
- CV
- Submission Type
- 510(k)