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FDA 510(k)

ARGYLE ACC-U-THERM W/TEMPERATURE PROBE

K-Number: K812976 · 1981-12-08

ApplicantSherwood Medical Co.
Decision Date1981-12-08
Product CodeBZT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

ARGYLE ACC-U-THERM W/TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Sherwood Medical Co.. It received FDA 510(k) clearance on 1981-12-08 under 510(k) number K812976. 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 ARGYLE ACC-U-THERM W/TEMPERATURE PROBE?

ARGYLE ACC-U-THERM W/TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1981-12-08. The listed applicant is Sherwood Medical Co.. The 510(k) number is K812976.

When did ARGYLE ACC-U-THERM W/TEMPERATURE PROBE receive FDA 510(k) clearance?

ARGYLE ACC-U-THERM W/TEMPERATURE PROBE received FDA 510(k) clearance on 1981-12-08, under 510(k) number K812976.

Who is the listed applicant for ARGYLE ACC-U-THERM W/TEMPERATURE PROBE?

The FDA 510(k) record lists Sherwood Medical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARGYLE ACC-U-THERM W/TEMPERATURE PROBE?

The FDA product code for ARGYLE ACC-U-THERM W/TEMPERATURE PROBE is BZT.

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Other records listing Sherwood Medical Co. 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.

K981365MAHURKAR 13.5 FR CUFFED CATHETER WITH CURVED EXTENSIONSK960982MONOJECT BLUNT I.V. ACCESS CANNULA/MONOJECT HYPODERMIC SYRINGE WITH BLUNT I.V. ACCESS CANNULAK962880SENSI-TOUCH COMBO SPINAL/EPIDURAL REGIONAL ANESTHESIA DELIVERY SYSTEMK960574ARGYLE TURKEL NEONATAL/PEDIATRIC THORACIC CATHETER INSERTION TRAY AND THORACIC CATHETER SYSTEMK960677KANGAROO JEJUNAL FEEDING SYSTEMK960632KANGAROO FEEDING TUBE PLACMENT STYLET

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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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