ACE COMPUTER SYSTEM— 510(k) K853482
Substantially EquivalentCardiac Medical Systems Corp.
FDA 510(k) clearance K853482 for ACE COMPUTER SYSTEM, Substantially Equivalent on 1986-01-01. Applicant: Cardiac Medical Systems Corp.. Device class: 1.
Clearance details
- Applicant
- Cardiac Medical Systems Corp.
- Product code
- Code IYX
- Device class
- Class 1
- Regulation
- 21 CFR 892.1100
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Springfield, WI, US
Recent devices under product code IYX
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