SONICAID MODEL D206E AIR EMBOLI-DETECT
FDA 510(k) clearance K833227 · decided 1983-10-27
Clearance details
- K-number
- K833227
- Device name
- SONICAID MODEL D206E AIR EMBOLI-DETECT
- Applicant
- Sonicaid, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-08-16
- Decision date
- 1983-10-27
- Days to decision
- 72 days
- Clearance type
- Traditional
- Product code
- LBA
- Device class
- 1
- Regulation number
- 862.3280
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.