The following data is part of a premarket notification filed by Alternative Design Systems, Inc. with the FDA for Accessory Ventillary(breathing) Frequency Monitor.
| Device ID | K852515 |
| 510k Number | K852515 |
| Device Name: | ACCESSORY VENTILLARY(BREATHING) FREQUENCY MONITOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Contact | John L Essmyer |
| Correspondent | John L Essmyer ALTERNATIVE DESIGN SYSTEMS, INC. 419 HACKENSACK AVE. Carlstadt, NJ 07072 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-13 |
| Decision Date | 1985-06-24 |