REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
FDA 510(k) clearance K082546 · decided 2008-12-02
Clearance details
- K-number
- K082546
- Device name
- REUSABLE OHMEDA (U410-02), DATEX (U410-09) COMPATABLE ADULT FINGER CLIP SENSOR, PHILLIPS ADULT SOFT TIP SENSOR(U403S-91)
- Applicant
- Unimed Medical Supplies, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-09-03
- Decision date
- 2008-12-02
- Days to decision
- 90 days
- Clearance type
- Traditional
- Product code
- DQA
- Device class
- 2
- Regulation number
- 870.2700
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Mukwonago, WI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.