SCANNER 560 ULTRASOUND SCANNER
FDA 510(k) clearance K827713 · decided 1982-08-10
Clearance details
- K-number
- K827713
- Device name
- SCANNER 560 ULTRASOUND SCANNER
- Applicant
- Pie Data, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1982-06-22
- Decision date
- 1982-08-10
- Days to decision
- 49 days
- Clearance type
- Traditional
- Advisory committee
- Unknown
- Location
- Singer Island, FL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Pie Data
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Recalls involving this device
No recalls on record reference this clearance.