FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHILIPS RT250 COLLIMATOR (PK8050)
K Number: K885126
·
Decision Jun 1, 1989
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
3
Applicant Total
14
Review Days
171
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Basic Information
- Device Name
- PHILIPS RT250 COLLIMATOR (PK8050)
- K Number
- K885126
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.5900
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Perkins Mfg. Co.
- Date Received
- December 12, 1988
- Decision Date
- June 1, 1989
- Product Code
- KQA
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| KQA | Device, Beam Limiting, X-Ray, Therapeutic | FDA class 2 | Radiology |
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| K895500 | PATIENT POSITIONING ACCESSORIES | Nov 6, 1989 | Substantially Equivalent |