510(k) K915255
- Device
- Cdi(tm) 300, 400 & 100, Modification
- Applicant
- 3M COMPANY
- 510(k) number
- K915255
- Product code
- DRY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1992-01-15
- Date received
- 1991-11-18
- Regulation
- 870.4330
- Classification name
- Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
- Medical specialty
- Cardiovascular
- Review panel
- Cardiovascular
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- STEVEN M ARICK
- Address
- 1311 Valencia Ave. Tustin CA US 92680 92680
FDA Registration Numbers#
- 3006073153
- 9617601
- 3002807561
- 2029275
- 3019807891
- 3016618143
- 9611109
- 1118880
- 2184009
- 2245590
- 1218950
- 1828100
- 2011171
- 1124841
- 1319639
- 3000126629
- 9680841
- 1928237
- 3002807090
Source Documents#
510(k) summary PDF not indicated by FDA
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