The following data is part of a premarket notification filed by Axelgaard Mfg. Co., Ltd. with the FDA for Pals Neonatal Pediatric Ecg Electrode, Models Pn100, Pn200.
| Device ID | K000206 |
| 510k Number | K000206 |
| Device Name: | PALS NEONATAL PEDIATRIC ECG ELECTRODE, MODELS PN100, PN200 |
| Classification | Electrode, Electrocardiograph |
| Applicant | AXELGAARD MFG. CO., LTD. 329 WEST AVIATION RD. Fallbrook, CA 92028 -3227 |
| Contact | Dan Jeffery |
| Correspondent | Dan Jeffery AXELGAARD MFG. CO., LTD. 329 WEST AVIATION RD. Fallbrook, CA 92028 -3227 |
| Product Code | DRX |
| CFR Regulation Number | 870.2360 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-21 |
| Decision Date | 2000-04-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851913006111 | K000206 | 000 |
| 00851913006104 | K000206 | 000 |
| 00851913006098 | K000206 | 000 |
| 00851913006081 | K000206 | 000 |
| 00851913006074 | K000206 | 000 |
| 00851913006067 | K000206 | 000 |
| B0361015663 | K000206 | 000 |
| B0361015662 | K000206 | 000 |