FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BLOOD GAS INCUBATOR #260650
K Number: K823766
·
Decision Feb 18, 1983
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
2
Applicant Total
3
Review Days
66
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- BLOOD GAS INCUBATOR #260650
- K Number
- K823766
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Boekel Industries, Inc.
- Date Received
- December 14, 1982
- Decision Date
- February 18, 1983
- Product Code
- JRG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| JRG | Block, Heating | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JRG), ordered by most recent decision date.
HEATING BLOCK, WAMPOLE 37 C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ENZAC INCUBATOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry