The following data is part of a premarket notification filed by Peace Medical, Inc. with the FDA for Pax Meter.
| Device ID | K853085 |
| 510k Number | K853085 |
| Device Name: | PAX METER |
| Classification | Pneumotachometer |
| Applicant | PEACE MEDICAL, INC. 9 GREAT MEADOW LN. East Hanover, NJ 07936 |
| Contact | Kevin Fegan |
| Correspondent | Kevin Fegan PEACE MEDICAL, INC. 9 GREAT MEADOW LN. East Hanover, NJ 07936 |
| Product Code | JAX |
| CFR Regulation Number | 868.2550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-07-23 |
| Decision Date | 1985-09-03 |