FDA 510(k)
FDA class 2
Substantially Equivalent for Some Indications
🇺🇸 United States
CHAL-2500
K Number: K946186
·
Decision Aug 14, 1995
Classifications
1
FEI Numbers
166
Registration Numbers
166
Same Product Code
543
Applicant Total
26
Review Days
237
Basic Information
- Device Name
- CHAL-2500
- K Number
- K946186
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 890.5850
- Medical Specialty
- Physical Medicine
- Decision
- Substantially Equivalent for Some Indications
- Applicant
- HOGAN & HARTSON
- Date Received
- December 20, 1994
- Decision Date
- August 14, 1995
- Product Code
- IPF
- Advisory Committee
- Physical Medicine
- Review Advisory Committee
- PM
- 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 |
|---|---|---|---|
| IPF | Stimulator, Muscle, Powered | FDA class 2 | Physical Medicine |
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