FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
K Number: K832374
·
Decision Dec 1, 1983
Classifications
1
FEI Numbers
25
Registration Numbers
25
Same Product Code
52
Applicant Total
18
Review Days
136
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Basic Information
- Device Name
- PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH
- K Number
- K832374
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2780
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Sonicaid, Inc.
- Date Received
- July 18, 1983
- Decision Date
- December 1, 1983
- Product Code
- JOM
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| JOM | Plethysmograph, Photoelectric, Pneumatic Or Hydraulic | FDA class 2 | Cardiovascular |
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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 |
| K833488 | SONICOMP | Nov 28, 1983 | Substantially Equivalent |
| K833227 | SONICAID MODEL D206E AIR EMBOLI-DETECT | Oct 27, 1983 | Substantially Equivalent |
| K831371 | MODEL FM5 | Jun 30, 1983 | Substantially Equivalent |