TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
FDA 510(k) clearance K904943 · decided 1991-04-26
Clearance details
- K-number
- K904943
- Device name
- TAPSCOPE ESOPHAGEAL CARDIAC RECORDING STETHOSCOPE
- Applicant
- Arzco Medical Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-11-01
- Decision date
- 1991-04-26
- Days to decision
- 176 days
- Clearance type
- Traditional
- Product code
- BZT
- Device class
- 2
- Regulation number
- 868.1920
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Vernon Hills, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|
| Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (K251025) | Covidien, LLC | 2025-12-29 |
| Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 French (K193027) | Deroyal Industries, Inc. | 2020-04-02 |
| ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (NON-STERILE),ESOPHAGEAL STETHOSCOPE TEMPERATURE WITH ATTACHED EAR PIECE (K140134) | Starboard Medical, LLC | 2014-06-16 |
| ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR (K111050) | Starboard Medical, LLC | 2012-04-12 |
| ESOPHAGEAL STETHOSCOPE (K092716) | Truer Medical, Inc. | 2009-09-17 |
| ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR (K072621) | Cincinnati Sub-Zero Products, Inc. | 2007-12-13 |
| LIFESOUND ESOPHAGEAL STETHOSCOPE (K062020) | Novamed, LLC | 2006-09-05 |
| ESOPHAGEAL STETHOSCOPE (K982193) | Shore Medical, Inc. | 1998-09-01 |
| DISPOSABLE ESOPHAGEAL STETHOSCOPE (K973839) | Catheter Research, Inc. | 1998-03-19 |
| ARISTO ESOPHAGEAL STETHOSCOPE (K961060) | Aristo Medical Products, Inc. | 1996-06-19 |
| INTROSCOPE (K953793) | Polamedco, Inc. | 1995-11-29 |
| ESOPHAGEAL STETHOSCOPE (K930929) | Coast Medical Corp. | 1995-03-17 |
Recalls involving this device
No recalls on record reference this clearance.