FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
K Number: K973162
·
Decision Nov 20, 1997
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
27
Applicant Total
26
Review Days
90
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Basic Information
- Device Name
- DUAL RADIATION TARGETING SYSTEM DRTS DRAPE
- K Number
- K973162
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 892.5780
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Hogan & Hartson
- Date Received
- August 22, 1997
- Decision Date
- November 20, 1997
- Product Code
- IWE
- Advisory Committee
- Radiology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| IWE | Monitor, Patient Position, Light-Beam | FDA class 1 | Radiology |
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