FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL FM5
K Number: K831371
·
Decision Jun 30, 1983
Classifications
1
FEI Numbers
55
Registration Numbers
55
Same Product Code
213
Applicant Total
18
Review Days
64
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Basic Information
- Device Name
- MODEL FM5
- K Number
- K831371
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.2740
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Sonicaid, Inc.
- Date Received
- April 27, 1983
- Decision Date
- June 30, 1983
- Product Code
- HGM
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGM | System, Monitoring, Perinatal | FDA class 2 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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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 |
| K832374 | PHOTOFLO DUAL-MODE PHOTOPLETHYSMOGRAPH | Dec 1, 1983 | Substantially Equivalent |
| K833488 | SONICOMP | Nov 28, 1983 | Substantially Equivalent |
| K833227 | SONICAID MODEL D206E AIR EMBOLI-DETECT | Oct 27, 1983 | Substantially Equivalent |