The following data is part of a premarket notification filed by Bio Protech, Inc. with the FDA for Pro-neo Neonatal Ecg Electrode, Models Sg15 And Sr20.
| Device ID | K053011 |
| 510k Number | K053011 |
| Device Name: | PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20 |
| Classification | Electrode, Electrocardiograph |
| Applicant | BIO PROTECH, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Contact | E.j. Smith |
| Correspondent | E.j. Smith BIO PROTECH, INC. 1676 VILLAGE GREEN SUITE A Crofton, MD 21114 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-10-26 |
| Decision Date | 2005-12-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817325021630 | K053011 | 000 |
| 18809083941441 | K053011 | 000 |
| 30888277688456 | K053011 | 000 |
| 20885380048446 | K053011 | 000 |
| 20885380048453 | K053011 | 000 |
| 50885380048461 | K053011 | 000 |
| 20885380048477 | K053011 | 000 |
| 20817325021603 | K053011 | 000 |
| 20817325021610 | K053011 | 000 |
| 20817325021627 | K053011 | 000 |
| 18809083941427 | K053011 | 000 |