FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
K Number: K050272
·
Decision Mar 24, 2005
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
22
Applicant Total
1
Review Days
48
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Basic Information
- Device Name
- CRYOMEDICAL INSTRUMENTS CRYO-PAC SYSTEMS
- K Number
- K050272
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 882.4250
- Medical Specialty
- Neurology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Cryomedical Instruments, Ltd.
- Date Received
- February 4, 2005
- Decision Date
- March 24, 2005
- Product Code
- GXH
- Advisory Committee
- Neurology
- 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 |
|---|---|---|---|
| GXH | Device, Surgical, Cryogenic | FDA class 2 | Neurology |
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