FDA 510(k)
FDA unclassified
Substantially Equivalent
🇺🇸 United States
HEALTH POINT
K Number: K781651
·
Decision Apr 3, 1979
Classifications
1
FEI Numbers
14
Registration Numbers
14
Same Product Code
22
Applicant Total
2
Review Days
188
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Basic Information
- Device Name
- HEALTH POINT
- K Number
- K781651
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Applicant
- Anritsu America Co.
- Date Received
- September 27, 1978
- Decision Date
- April 3, 1979
- Product Code
- BWK
- Advisory Committee
- Unknown
- 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 |
|---|---|---|---|
| BWK | Stimulator, Electro-Acupuncture | FDA unclassified | Unknown |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BWK), ordered by most recent decision date.
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Other Clearances by Anritsu America Co.
| K Number | Device Name | ||
|---|---|---|---|
| K811499 | TENSMAX | Aug 20, 1981 | Substantially Equivalent |