FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AMEDA HAND BREAST PUMP
K Number: K823591
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
91
Registration Numbers
91
Same Product Code
26
Applicant Total
10
Review Days
22
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Basic Information
- Device Name
- AMEDA HAND BREAST PUMP
- K Number
- K823591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 884.5150
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Burditt & Calkins-Siemens-Elema
- Date Received
- December 6, 1982
- Decision Date
- December 28, 1982
- Product Code
- HGY
- 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 |
|---|---|---|---|
| HGY | Pump, Breast, Non-Powered | FDA class 1 | Obstetrics/Gynecology |
Similar 510(k) Clearances
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WHITE RIVER MINI MANUAL BREAST PUMP
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EVERT-IT
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Other Clearances by Burditt & Calkins-Siemens-Elema
| K Number | Device Name | ||
|---|---|---|---|
| K833519 | PULSE GENERATOR MODEL 688 | Jan 30, 1984 | Substantially Equivalent |
| K833155 | RAYDEN MEDICAL MINI PULSE VOLUME RECORD | Jan 26, 1984 | Substantially Equivalent |
| K830344 | SIEMENS-ELMA PULSE GENERATOR #718 | May 27, 1983 | Substantially Equivalent |
| K823435 | MON-A-THERM MYOCARDIAL TEMP. SENSOR | Dec 30, 1982 | Substantially Equivalent |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | Oct 4, 1982 | Substantially Equivalent |
| K821712 | INFORMED REMOTE FIELD UNIT MODEL IFM1000 | Jul 26, 1982 | Substantially Equivalent |
| K803111 | ERECTAID | Jan 23, 1981 | Substantially Equivalent |
| K802607 | TERPERATUR SENSING DEVICE | Nov 19, 1980 | Substantially Equivalent |
| K760787 | LIBERATOR/STROLLER | Oct 22, 1976 | Substantially Equivalent |