IGAR System (1001.A)— 510(k) K223484
Substantially EquivalentInsight Medbotics, Inc.
FDA 510(k) clearance K223484 for IGAR System (1001.A), Substantially Equivalent on 2023-07-20. Applicant: Insight Medbotics, Inc.. Device class: 2.
Clearance details
- Applicant
- Insight Medbotics, Inc.
- Product code
- Code MOS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1000
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Hamilton, CA
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Data sourced from openFDA. This site is unofficial and independent of the FDA.