The following data is part of a premarket notification filed by Kepler Medtec with the FDA for Ecg Single Patient Use Lead Wire Set, Models 2048801-5 To 2048801-8.
| Device ID | K101660 |
| 510k Number | K101660 |
| Device Name: | ECG SINGLE PATIENT USE LEAD WIRE SET, MODELS 2048801-5 TO 2048801-8 |
| Classification | Cable, Transducer And Electrode, Patient, (including Connector) |
| Applicant | KEPLER MEDTEC 200 Homer Ave Ashland, MA 01721 |
| Contact | F. David Rothkopf |
| Correspondent | F. David Rothkopf KEPLER MEDTEC 200 Homer Ave Ashland, MA 01721 |
| Product Code | DSA |
| CFR Regulation Number | 870.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-14 |
| Decision Date | 2010-08-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20889483577445 | K101660 | 000 |
| 20889483618353 | K101660 | 000 |
| 20889483618346 | K101660 | 000 |
| 20889483618339 | K101660 | 000 |
| 20889483618322 | K101660 | 000 |
| 20889483577483 | K101660 | 000 |
| 20889483577476 | K101660 | 000 |
| 20889483577452 | K101660 | 000 |
| 20889483576783 | K101660 | 000 |
| 20889483576776 | K101660 | 000 |
| 20889483576769 | K101660 | 000 |
| 20889483576752 | K101660 | 000 |
| 20889483576714 | K101660 | 000 |
| 20889483618360 | K101660 | 000 |
| 20889483618407 | K101660 | 000 |
| 20889483576837 | K101660 | 000 |
| 20889483576820 | K101660 | 000 |
| 20889483576813 | K101660 | 000 |
| 20889483576806 | K101660 | 000 |
| 20889483576790 | K101660 | 000 |
| 20889483576691 | K101660 | 000 |
| 20889483576684 | K101660 | 000 |
| 20889483576677 | K101660 | 000 |
| 20889483618452 | K101660 | 000 |
| 20889483618445 | K101660 | 000 |
| 20889483618421 | K101660 | 000 |
| 20889483618414 | K101660 | 000 |
| 20889483576707 | K101660 | 000 |