FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SONICAID MODEL D206E AIR EMBOLI-DETECT
K Number: K833227
·
Decision Oct 27, 1983
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
18
Review Days
72
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SONICAID MODEL D206E AIR EMBOLI-DETECT
- K Number
- K833227
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.3280
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Sonicaid, Inc.
- Date Received
- August 16, 1983
- Decision Date
- October 27, 1983
- Product Code
- LBA
- Advisory Committee
- Clinical Toxicology
- Review Advisory Committee
- TX
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LBA | Procainamide Control Materials | FDA class 1 | Clinical Toxicology |
Other Clearances by Sonicaid, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873673 | BV105 (&BV105R) VASCULAR FLOW DETECTOR W/OPTIONAL | Feb 26, 1988 | Substantially Equivalent |
| K872074 | 5 MHZ TRANSDUCER | Aug 25, 1987 | Substantially Equivalent |
| K863803 | VASOPULSE(TM)/MODEL 5000 | May 6, 1987 | Substantially Equivalent |
| K862720 | VASOFLO-3 & EXTRAVASCULAR BLOOD FLOW PROBES | Nov 17, 1986 | Substantially Equivalent |
| K861237 | VASOVIEW DUPLEX IMAGING SYSTEM | Jul 14, 1986 | Substantially Equivalent for Some Indications |
| K851102 | VASOSCREEN IMPEDANCE PLETHYSMOGRAPH | May 16, 1985 | Substantially Equivalent |
| K833902 | VASOSCAN | Jan 27, 1984 | Substantially Equivalent |
| K832374 | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH | Dec 1, 1983 | Substantially Equivalent |
| K833488 | SONICOMP | Nov 28, 1983 | Substantially Equivalent |
| K831371 | MODEL FM5 | Jun 30, 1983 | Substantially Equivalent |