FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
INFORMED REMOTE FIELD UNIT MODEL IFM1000
K Number: K821712
·
Decision Jul 26, 1982
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
62
Applicant Total
10
Review Days
47
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Basic Information
- Device Name
- INFORMED REMOTE FIELD UNIT MODEL IFM1000
- K Number
- K821712
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1890
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Burditt & Calkins-Siemens-Elema
- Date Received
- June 9, 1982
- Decision Date
- July 26, 1982
- Product Code
- BTY
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| BTY | Calculator, Predicted Values, Pulmonary Function | FDA class 2 | Anesthesiology |
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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 |
| K823591 | AMEDA HAND BREAST PUMP | Dec 28, 1982 | Substantially Equivalent |
| K822239 | COAXIAL BIPOLAR PACING ELECTRODE | Oct 4, 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 |