AN1036 Dosimeter
FDA 510(k) clearance K200334 · decided 2020-11-12
Clearance details
- K-number
- K200334
- Device name
- AN1036 Dosimeter
- Applicant
- Andersen Sterilizers, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2020-02-11
- Decision date
- 2020-11-12
- Days to decision
- 275 days
- Clearance type
- Traditional
- Product code
- JOJ
- Device class
- 2
- Regulation number
- 880.2800
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Haw River, NC, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.