FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BITESTRIP
K Number: K030869
·
Decision May 14, 2004
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
18
Applicant Total
5
Review Days
422
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Basic Information
- Device Name
- BITESTRIP
- K Number
- K030869
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.1375
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- S.L.P. , Ltd.
- Date Received
- March 19, 2003
- Decision Date
- May 14, 2004
- Product Code
- KZM
- Advisory Committee
- Physical Medicine
- 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 |
|---|---|---|---|
| KZM | Device, Muscle Monitoring | FDA class 2 | Physical Medicine |
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