FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
K Number: K900385
·
Decision Jul 9, 1991
Classifications
1
FEI Numbers
121
Registration Numbers
121
Same Product Code
397
Applicant Total
14
Review Days
526
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Basic Information
- Device Name
- ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE
- K Number
- K900385
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1025
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Parexel Intl. Corp.
- Date Received
- January 29, 1990
- Decision Date
- July 9, 1991
- Product Code
- DSI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSI | Detector And Alarm, Arrhythmia | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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