ULTRA IMAGER— 510(k) K800553
Substantially EquivalentHoneywell, Inc.
FDA 510(k) clearance K800553 for ULTRA IMAGER, Substantially Equivalent on 1980-07-21. Applicant: Honeywell, Inc.. Device class: 2.
Clearance details
- Applicant
- Honeywell, Inc.
- Product code
- Code DXK
- Device class
- Class 2
- Regulation
- 21 CFR 870.2330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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