510(k) K833227
- Device
- SONICAID MODEL D206E AIR EMBOLI-DETECT
- Applicant
- SONICAID, INC.
- 510(k) number
- K833227
- Product code
- LBA
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-10-27
- Date received
- 1983-08-16
- Regulation
- 862.3280
- Classification name
- Procainamide Control Materials
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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