The following data is part of a premarket notification filed by Spiracle Technology with the FDA for Spiracle Technology-bi-flow Demand/resuscitator Valve, Model 504.
| Device ID | K982225 |
| 510k Number | K982225 |
| Device Name: | SPIRACLE TECHNOLOGY-BI-FLOW DEMAND/RESUSCITATOR VALVE, MODEL 504 |
| Classification | Ventilator, Emergency, Powered (resuscitator) |
| 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 | BTL |
| CFR Regulation Number | 868.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-06-24 |
| Decision Date | 1998-10-28 |
| Summary: | summary |