Electronics For Medicine, Inc. FDA Record
Electronics For Medicine, Inc. has 0 FDA recalls, 0 inspections, 9 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Electronics For Medicine, Inc." is on file.
- Latest 510(k)
- Jun 22, 1983
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 9 | Nov 8, 2026 | File dated Nov 2, 2026 | Current |
| Inspections | 0 | Nov 14, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions | 0 | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
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Recent 510(k) clearances
| K-Number | Device | Date |
|---|---|---|
| K830791 | UNIVERSAL MEDDARS SYSTEM | Jun 22, 1983 |
| K830795 | CABINET FOR MULTIPLE FUNCTION BLOCKS | May 18, 1983 |
| K792528 | RESPIRATION/APNEA AMPLIFIER MODEL 3105 | Feb 21, 1980 |
| K791006 | SMART BILECTRODES | Jun 11, 1979 |
| K790198 | MONITOR PLUG-IN MODEL M1106 ECG | Mar 6, 1979 |
| K790203 | INTERVAL TIMER MODEL V4295 | Mar 2, 1979 |
| K790185 | MODEL V 4207 INTEGRATING PLUG-IN | Feb 16, 1979 |
| K780107 | ANALYZER-PLUG-IN, CO2 MODEL M 3104 | Jan 30, 1978 |
| K770366 | ISOLATED ELECTROCARDIOGRAPH MODEL 1207 | Mar 1, 1977 |
Electronics For Medicine, Inc. and the FDA: common questions
Has Electronics For Medicine, Inc. received an FDA warning letter?
No FDA warning letter addressed to the name "Electronics For Medicine, Inc." is on file. This answer covers that name only: letters addressed to a related company name or to one of its sites are listed on that name's or site's own page.
Has Electronics For Medicine, Inc. received an FDA Form 483?
FDA has not published a Form 483 for "Electronics For Medicine, Inc." in its reading room. FDA publishes some Form 483s, not all of them.
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