Elmed, Inc.
Mchenry, IL, US
Elmed, Inc. appears in FDA device records in Mchenry, IL. FDA records list 11 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 11
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 11 510(k) clearances for Elmed, Inc. between 1977 and 1984. The busiest year on record is 1979, with 4. The most recent is 1984, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 2 |
| 1978 | 1 |
| 1979 | 4 |
| 1981 | 1 |
| 1983 | 1 |
| 1984 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K832589 | ELMED WMC 10 AND BC 50 M/M | Substantially Equivalent | ||
| K840321 | ENDODYNE DUAL | LIH | Substantially Equivalent | |
| K832393 | ENCODYNE 4 & VACUFIX 4 | Substantially Equivalent | ||
| K810529 | DIRECT WRITING VECTORCARDIOGRAPH | DYC | Substantially Equivalent | |
| K791279 | KOLPOSKOP KP20005 | HEX | Substantially Equivalent | |
| K791280 | OPERATION MICROSCOPE SOM 1 | FSO | Substantially Equivalent | |
| K790794 | SIEMENS CARDIOSTAT 701 | DPS | Substantially Equivalent | |
| K790033 | HVG-100 | IPF | Substantially Equivalent | |
| K781455 | SIEMENS ULTRATHERM 708 | IMJ | Substantially Equivalent | |
| K770782 | FIBERSCOPIC SCOPE RECORDER SYSTEM | GWK | Substantially Equivalent | |
| K770777 | THERMOMETER, ELECTRONIC, DIGIMED HOL | FLL | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- HEXColposcope (And Colpomicroscope)
- GWKConditioner, Signal, Physiological
- FLLContinuous Measurement Thermometer
- IMJDiathermy, Shortwave, For Use In Applying Therapeutic Deep Heat
- DPSElectrocardiograph
- LIHInterferential Current Therapy
- FSOMicroscope, Surgical, General & Plastic Surgery
- IPFStimulator, Muscle, Powered
- DYCVectorcardiograph
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain