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FDA 510(k)

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE

K-Number: K810147 · 1981-02-05

ApplicantPortex, Inc.
Decision Date1981-02-05
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Portex, Inc.. It received FDA 510(k) clearance on 1981-02-05 under 510(k) number K810147. The device is classified under product code BZT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE?

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1981-02-05. The listed applicant is Portex, Inc.. The 510(k) number is K810147.

When did ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE receive FDA 510(k) clearance?

ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE received FDA 510(k) clearance on 1981-02-05, under 510(k) number K810147.

Who is the listed applicant for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE?

The FDA 510(k) record lists Portex, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE?

The FDA product code for ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBE is BZT.

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Other records listing Portex, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K033080PORTEX 24G PEDIATRIC EPIDURAL AND PERIPHERAL BLOCK ANESTHESIA CATHETERK031057PER-FIT PERCUTANEOUS DILATIONAL TRACHEOSTOMY KITK0237931ST RESPONSE INTERMEDIATE MANUAL RESUSCITATORK0141151ST RESPONSE MANUAL RESUSCITATOR, MODEL 85XXK014073HYPODERMIC NEEDLE-PRO INSULIN SYRINE & NEEDLE WITH NEEDLE PROTECTION DEVICEK873992LARYNGECTOMY TUBE

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Related Devices (Code: BZT)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251025Mon-a-Therm™ Esophageal Stethoscope with Temperature Sensor 400TM (90041, 90042, 90043, 90049)Covidien, LLCK193027Esophageal Stethoscope 9 French, Esophageal Stethoscope 12 French, Esophageal Stethoscope 18 French, Esophageal Stethoscope, 24 FrenchDeroyal Industries, Inc.K111050ESOPHAGEAL / RECTAL TEMPERATURE PROBE, 9FR, 12FR, ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSOR, 9FR, 12FR, 18FR, 24FRStarboard Medical, LLCK092716ESOPHAGEAL STETHOSCOPETruer Medical, Inc.K072621ESOPHAGEAL/RECTAL TEMPERATURE PROBE AND ESOPHAGEAL STETHOSCOPE WITH TEMPERATURE SENSORCincinnati Sub-Zero Products, Inc.K062020LIFESOUND ESOPHAGEAL STETHOSCOPENovamed, LLC

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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