MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ— 510(k) K981641
Substantially EquivalentInstrumentarium Corp.
FDA 510(k) clearance K981641 for MAMMOGRAPHY X-RAY EQUIPMENT MODELS MGF101 AND MGF110, ALPHA III, ALPHA ST, ALPHA RT AND ALPHA IQ, Substantially Equivalent on 1998-07-17. Applicant: Instrumentarium Corp.. Device class: 2.
Clearance details
- Applicant
- Instrumentarium Corp.
- Product code
- Code IZH
- Device class
- Class 2
- Regulation
- 21 CFR 892.1710
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Milwaukee, WI, US
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