510(k) K811397
K811397 is an FDA 510(k) premarket notification submitted by Gillco, Inc. for the device "ECA". The FDA issued a decision of Substantially Equivalent on July 2, 1981. The device falls under product code FOA (Board, Cardiopulmonary), a Class I device regulated under 21 CFR 880.6080.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 2, 1981
- Date Received
- May 18, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Board, Cardiopulmonary
- Device Class
- Class I
- Regulation Number
- 880.6080
- Review Panel
- HO
- Submission Type