The following data is part of a premarket notification filed by Accutron, Inc. with the FDA for Guardian Low Pressure Alarm Accessory, Model 34076.
| Device ID | K992421 |
| 510k Number | K992421 |
| Device Name: | GUARDIAN LOW PRESSURE ALARM ACCESSORY, MODEL 34076 |
| Classification | Gas-machine, Anesthesia |
| Applicant | ACCUTRON, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027 |
| Contact | Dottie Knechtel |
| Correspondent | Dottie Knechtel ACCUTRON, INC. 2020 WEST MELINDA LN. Phoenix, AZ 85027 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-21 |
| Decision Date | 1999-10-27 |
| Summary: | summary |