The following data is part of a premarket notification filed by Respiratory Support Products, Inc. with the FDA for Acoustascope Esophageal Stethoscope W/temp Sensor.
| Device ID | K854212 |
| 510k Number | K854212 |
| Device Name: | ACOUSTASCOPE ESOPHAGEAL STETHOSCOPE W/TEMP SENSOR |
| Classification | Stethoscope, Esophageal, With Electrical Conductors |
| Applicant | RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Contact | Steve Georgevich |
| Correspondent | Steve Georgevich RESPIRATORY SUPPORT PRODUCTS, INC. 3183-D AIRWAY AVE. Costa Mesa, CA 92626 |
| Product Code | BZT |
| CFR Regulation Number | 868.1920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-10-17 |
| Decision Date | 1986-01-03 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10695085000372 | K854212 | 000 |
| 10695085000266 | K854212 | 000 |
| 10695085000273 | K854212 | 000 |
| 10695085000280 | K854212 | 000 |
| 10695085000297 | K854212 | 000 |
| 10695085000303 | K854212 | 000 |
| 10695085000310 | K854212 | 000 |
| 10695085000327 | K854212 | 000 |
| 10695085000334 | K854212 | 000 |
| 10695085000358 | K854212 | 000 |
| 10695085000365 | K854212 | 000 |
| 35019517059209 | K854212 | 000 |