6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
FDA 510(k) clearance K844772 · decided 1986-04-17
Clearance details
- K-number
- K844772
- Device name
- 6.0 MHZ LA6060 TRANSDUCER & 4.0 MHZ LA4011 TRANSDU
- Applicant
- Philips Medical Systems, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-12-05
- Decision date
- 1986-04-17
- Days to decision
- 498 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- 5680 Da Best, NL
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
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Recalls involving this device
No recalls on record reference this clearance.