The following data is part of a premarket notification filed by Kendall-ltp with the FDA for Disposable Ecg Electrode.
| Device ID | K953649 |
| 510k Number | K953649 |
| Device Name: | DISPOSABLE ECG ELECTRODE |
| Classification | Electrode, Electrocardiograph |
| Applicant | KENDALL-LTP 2 LUDLOW PARK DR. Chicopee, MA 01022 |
| Contact | Warren Howland |
| Correspondent | Warren Howland KENDALL-LTP 2 LUDLOW PARK DR. Chicopee, MA 01022 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-08-04 |
| Decision Date | 1996-06-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884838007783 | K953649 | 000 |