PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM— 510(k) K885327
Substantially EquivalentPhilips Medical Systems North America, Inc.
FDA 510(k) clearance K885327 for PHILIPS DIGITAL CARDIAC IMAGING (DCI) SYSTEM, Substantially Equivalent on 1989-05-11. Applicant: Philips Medical Systems North America, Inc.. Device class: 1.
Clearance details
- Applicant
- Philips Medical Systems North America, Inc.
- Product code
- Code LMB
- Device class
- Class 1
- Regulation
- 21 CFR 892.2010
- 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.