FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TRANSPAC(R) II, DISPOSABLE TRANSDUCER
K Number: K884823
·
Decision Jul 3, 1990
Classifications
1
FEI Numbers
65
Registration Numbers
66
Same Product Code
104
Applicant Total
883
Review Days
592
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Basic Information
- Device Name
- TRANSPAC(R) II, DISPOSABLE TRANSDUCER
- K Number
- K884823
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.1620
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- November 18, 1988
- Decision Date
- July 3, 1990
- Product Code
- GWM
- Advisory Committee
- Neurology
- Review Advisory Committee
- NE
- 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 |
|---|---|---|---|
| GWM | Device, Monitoring, Intracranial Pressure | FDA class 2 | Neurology |
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