510(k) K823766
K823766 is an FDA 510(k) premarket notification submitted by Boekel Industries, Inc. for the device "BLOOD GAS INCUBATOR #260650". The FDA issued a decision of Substantially Equivalent on February 18, 1983. The device falls under product code JRG (Block, Heating), a Class I device regulated under 21 CFR 862.2050. Boekel Industries, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 1983
- Date Received
- December 14, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Block, Heating
- Device Class
- Class I
- Regulation Number
- 862.2050
- Review Panel
- CH
- Submission Type