FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BCD-HPP41C INTERFACE
K Number: K810968
·
Decision Apr 23, 1981
Classifications
1
FEI Numbers
115
Registration Numbers
116
Same Product Code
77
Applicant Total
27
Review Days
14
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Basic Information
- Device Name
- BCD-HPP41C INTERFACE
- K Number
- K810968
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2100
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Dynatech Corp.
- Date Received
- April 9, 1981
- Decision Date
- April 23, 1981
- Product Code
- JQP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JQP | Calculator/Data Processing Module, For Clinical Use | FDA class 1 | Clinical Chemistry |
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