FDA 510(k)
FDA unclassified
Substantially Equivalent
🇨🇦 Canada
GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
K Number: K963497
·
Decision Nov 8, 1996
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
15
Applicant Total
2
Review Days
66
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Basic Information
- Device Name
- GAMMACELL 3000 ELAN, VERSION 1.0 AND GAMMACELL 1000 ELITE, VERSION 1.0
- K Number
- K963497
- Device Class
- FDA unclassified
- Clearance Type
- Traditional
- Medical Specialty
- Unknown
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Nordion International, Inc.
- Date Received
- September 3, 1996
- Decision Date
- November 8, 1996
- Product Code
- MOT
- Advisory Committee
- Unknown
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | FDA unclassified | Unknown |
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Other Clearances by Nordion International, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952291 | GAMMACELL 3000 ELAN | Aug 25, 1995 | Substantially Equivalent |