MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
FDA 510(k) clearance K013205 · decided 2002-07-02
Clearance details
- K-number
- K013205
- Device name
- MILLAR PRESSURE CONTROL UNIT MODEL PCU-2000
- Applicant
- Millar Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2001-09-25
- Decision date
- 2002-07-02
- Days to decision
- 280 days
- Clearance type
- Traditional
- Product code
- DRQ
- Device class
- 2
- Regulation number
- 870.2060
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Houston, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.