LASER ALIGNMENT TOOL— 510(k) K943381
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K943381 for LASER ALIGNMENT TOOL, Substantially Equivalent on 1994-08-09. Applicant: Philips Medical Systems North America, Inc.. Device class: 1.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code IWE
- Device class
- Class 1
- Regulation
- 21 CFR 892.5780
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shelton, CT, US
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Data sourced from openFDA. This site is unofficial and independent of the FDA.