Atlas FDA

STETHOSCOPE WITH TEMPERATURE SENSOR

FDA 510(k) clearance K791190 · decided 1979-07-06

Clearance details

K-number
K791190
Device name
STETHOSCOPE WITH TEMPERATURE SENSOR
Applicant
National Catheter Co. Div. Mallinckrodt
Decision
Substantially Equivalent
Date received
1979-06-26
Decision date
1979-07-06
Days to decision
10 days
Clearance type
Traditional
Product code
BZT
Device class
2
Regulation number
868.1920
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Mchenry, 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.

RecordFirmDate
Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049) (K251025)Covidien, LLC2025-12-29
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, LLC2014-06-16
ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FR (K111050)Starboard Medical, LLC2012-04-12
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, LLC2006-09-05
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.