COOK MINI-INCUBATOR
FDA 510(k) clearance K983642 · decided 1999-02-01
Clearance details
- K-number
- K983642
- Device name
- COOK MINI-INCUBATOR
- Applicant
- Cook Ob/Gyn
- Decision
- Substantially Equivalent
- Date received
- 1998-10-16
- Decision date
- 1999-02-01
- Days to decision
- 108 days
- Clearance type
- Traditional
- Product code
- MQG
- Device class
- 2
- Regulation number
- 884.6120
- Medical specialty
- Obstetrics/Gynecology
- Advisory committee
- Obstetrics/Gynecology
- Location
- Spencer, IN, US
- Third-party review
- No
- Expedited review
- No
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