MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER
FDA 510(k) clearance K860235 · decided 1986-05-15
Clearance details
- K-number
- K860235
- Device name
- MOD 426, MEDICAL ULTRASONIC DIAGNOSTC TRANSDUCER
- Applicant
- Hoffrel Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-01-22
- Decision date
- 1986-05-15
- Days to decision
- 113 days
- Clearance type
- Traditional
- Product code
- ITX
- Device class
- 2
- Regulation number
- 892.1570
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- South Norwalk, CT, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.