The following data is part of a premarket notification filed by Tronomed, Inc. with the FDA for Lifelinc Leadwire.
| Device ID | K853303 |
| 510k Number | K853303 |
| Device Name: | LIFELINC LEADWIRE |
| Classification | Monitor, Breathing Frequency |
| Applicant | TRONOMED, INC. 2811 MCGAW Irvine, CA 92714 |
| Contact | Jim Lelten |
| Correspondent | Jim Lelten TRONOMED, INC. 2811 MCGAW Irvine, CA 92714 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-08-06 |
| Decision Date | 1985-09-18 |