FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
THUMPER MODEL P-1000
K Number: K880597
·
Decision Mar 29, 1988
Classifications
1
FEI Numbers
37
Registration Numbers
37
Same Product Code
55
Applicant Total
2
Review Days
47
Basic Information
- Device Name
- THUMPER MODEL P-1000
- K Number
- K880597
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5665
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- MICRO TEK ENGINEERING
- Date Received
- February 11, 1988
- Decision Date
- March 29, 1988
- Product Code
- BYI
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BYI | Percussor, Powered-Electric | FDA class 2 | Anesthesiology |
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Other Clearances by MICRO TEK ENGINEERING
| K Number | Device Name | ||
|---|---|---|---|
| K880252 | THERMAL-PAK MODEL SW 1000 | Feb 10, 1988 | Substantially Equivalent |