FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENZAC INCUBATOR
K Number: K781501
·
Decision Oct 3, 1978
Classifications
1
FEI Numbers
23
Registration Numbers
23
Same Product Code
2
Applicant Total
632
Review Days
34
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Basic Information
- Device Name
- ENZAC INCUBATOR
- K Number
- K781501
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Bd Becton Dickinson Vacutainer Systems Preanalytic
- Date Received
- August 30, 1978
- Decision Date
- October 3, 1978
- 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.
BLOOD GAS INCUBATOR #260650
FDA 510(k)
FDA Class 1
·Clinical Chemistry
HEATING BLOCK, WAMPOLE 37 C
FDA 510(k)
FDA Class 1
·Clinical Chemistry
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