510(k) K822873
K822873 is an FDA 510(k) premarket notification submitted by Eko Scann AB for the device "DEVETHERM". The FDA issued a decision of Substantially Equivalent on March 24, 1983. The device falls under product code DQB (Phlebograph, Impedance), a Class II device regulated under 21 CFR 870.2750. Eko Scann AB has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1983
- Date Received
- September 27, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phlebograph, Impedance
- Device Class
- Class II
- Regulation Number
- 870.2750
- Review Panel
- CV
- Submission Type