The following data is part of a premarket notification filed by Simplex Medical Corp. with the FDA for Simplex Universal Heated Tubing Sleeve.
| Device ID | K881451 |
| 510k Number | K881451 |
| Device Name: | SIMPLEX UNIVERSAL HEATED TUBING SLEEVE |
| Classification | Heater, Breathing System W/wo Controller (not Humidifier Or Nebulizer |
| Applicant | SIMPLEX MEDICAL CORP. 8920 LIMONITE, SUITE 291 Riverside, CA 92509 |
| Contact | Stiles Iii |
| Correspondent | Stiles Iii SIMPLEX MEDICAL CORP. 8920 LIMONITE, SUITE 291 Riverside, CA 92509 |
| Product Code | BZE |
| CFR Regulation Number | 868.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-06 |
| Decision Date | 1988-06-10 |