FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ABIOMED PERIOTEMP(TM) PROBE
K Number: K885075
·
Decision Feb 13, 1989
Classifications
1
FEI Numbers
139
Registration Numbers
139
Same Product Code
7
Applicant Total
19
Review Days
67
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Basic Information
- Device Name
- ABIOMED PERIOTEMP(TM) PROBE
- K Number
- K885075
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Abiomed, Inc.
- Date Received
- December 8, 1988
- Decision Date
- February 13, 1989
- Product Code
- EIL
- Advisory Committee
- Dental
- Review Advisory Committee
- DE
- 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 |
|---|---|---|---|
| EIL | Gauge, Depth, Instrument, Dental | FDA class 1 | Dental |
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