DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
FDA 510(k) clearance K935782 · decided 1994-08-01
Clearance details
- K-number
- K935782
- Device name
- DTX AND DTX PLUS DISPOSABLE PRESSURE TRANSDUCERS AND ACCESSORIES
- Applicant
- Ohmeda Medical
- Decision
- Substantially Equivalent
- Date received
- 1993-12-06
- Decision date
- 1994-08-01
- Days to decision
- 238 days
- Clearance type
- Traditional
- Product code
- DXN
- Device class
- 2
- Regulation number
- 870.1130
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Oxnard, CA, US
- Third-party review
- No
- Expedited review
- No
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