IMAGE MANAGEMENT SYSTEM
FDA 510(k) clearance K033870 · decided 2004-03-12
Clearance details
- K-number
- K033870
- Device name
- IMAGE MANAGEMENT SYSTEM
- Applicant
- Welch Allyn, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2003-12-12
- Decision date
- 2004-03-12
- Days to decision
- 91 days
- Clearance type
- Traditional
- Product code
- HEX
- Device class
- 2
- Regulation number
- 884.1630
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Skaneateles Falls, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.