The following data is part of a premarket notification filed by Quantum Life Systems, Inc. with the FDA for Pe-3000 Pulse Rate Monitor.
| Device ID | K854198 |
| 510k Number | K854198 |
| Device Name: | PE-3000 PULSE RATE MONITOR |
| Classification | Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) |
| Applicant | QUANTUM LIFE SYSTEMS, INC. RD 1, BOX 253 HILLCREST DRIVE Great Meadows, NJ 07838 |
| Contact | Linda D Baker |
| Correspondent | Linda D Baker QUANTUM LIFE SYSTEMS, INC. RD 1, BOX 253 HILLCREST DRIVE Great Meadows, NJ 07838 |
| Product Code | DRT |
| CFR Regulation Number | 870.2300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-15 |
| Decision Date | 1986-03-13 |