Quinton Electrophysiology Corp. FDA Record
Quinton Electrophysiology Corp. has 0 FDA recalls, 0 inspections, 3 510(k) clearances and 0 compliance actions on record. No FDA warning letter addressed to "Quinton Electrophysiology Corp." is on file.
- Latest 510(k)
- Dec 29, 1997
Summary
| Records | Count | Last refreshed | Source as of | Status |
|---|---|---|---|---|
| Recalls | 0 | Nov 8, 2026 | File dated Nov 3, 2026 | Current |
| 510(k) clearances | 3 | 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 |
|---|---|---|
| K971570 | EPXPRESS SYSTEM (TIMBERWOLF REVISION) /000391 | Dec 29, 1997 |
| K925346 | EP AMP, MODEL #901 | Apr 30, 1993 |
| K893836 | EPLAB (ELECTROCARDIOGRAPHIC MONITOR) | Sep 8, 1989 |
Quinton Electrophysiology Corp. and the FDA: common questions
Has Quinton Electrophysiology Corp. received an FDA warning letter?
No FDA warning letter addressed to the name "Quinton Electrophysiology Corp." 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 Quinton Electrophysiology Corp. received an FDA Form 483?
FDA has not published a Form 483 for "Quinton Electrophysiology Corp." in its reading room. FDA publishes some Form 483s, not all of them.
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