The following data is part of a premarket notification filed by Spiracle Technology with the FDA for Tsx Prm Pulmonary Resuscitation Monitor.
| Device ID | K973347 |
| 510k Number | K973347 |
| Device Name: | TSX PRM PULMONARY RESUSCITATION MONITOR |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | SPIRACLE TECHNOLOGY 16520 HARBOR BLVD., UNIT D Fountain Valley, CA 92708 |
| Contact | Guy Gansel |
| Correspondent | Guy Gansel SPIRACLE TECHNOLOGY 16520 HARBOR BLVD., UNIT D Fountain Valley, CA 92708 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-05 |
| Decision Date | 1998-07-23 |
| Summary: | summary |