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FDA 510(k)

BT-338N ELECTRONIC CLINICAL THERMOMETER

K-Number: K894627 · 1989-10-23

ApplicantIntegrated Display Technology, Ltd.
Decision Date1989-10-23
Product CodeFCI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BT-338N ELECTRONIC CLINICAL THERMOMETER is the device name listed in this FDA 510(k) record. The listed applicant is Integrated Display Technology, Ltd.. It received FDA 510(k) clearance on 1989-10-23 under 510(k) number K894627. The device is classified under product code FCI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BT-338N ELECTRONIC CLINICAL THERMOMETER?

BT-338N ELECTRONIC CLINICAL THERMOMETER is a medical device that received FDA 510(k) clearance on 1989-10-23. The listed applicant is Integrated Display Technology, Ltd.. The 510(k) number is K894627.

When did BT-338N ELECTRONIC CLINICAL THERMOMETER receive FDA 510(k) clearance?

BT-338N ELECTRONIC CLINICAL THERMOMETER received FDA 510(k) clearance on 1989-10-23, under 510(k) number K894627.

Who is the listed applicant for BT-338N ELECTRONIC CLINICAL THERMOMETER?

The FDA 510(k) record lists Integrated Display Technology, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BT-338N ELECTRONIC CLINICAL THERMOMETER?

The FDA product code for BT-338N ELECTRONIC CLINICAL THERMOMETER is FCI.

Related Clinical Trials

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Other records listing Integrated Display Technology, Ltd. 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.

K951977DIGITAL BLOOD PRESSURE METER - MODEL NO.: BPM883K941490BLOOD PRESSURE METER MODEL NO. BPM888K942336AUTOMATIC DIGITAL BLOOD PRESSURE MONITORK853130INTEGRATED DISPLAY TECHNOLOGY LTD.

Related Devices (Code: FCI)

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.

K895885AUTOMATED DISPOSABLE SOFT TISSUE BIOPSY CUTTINGNational-Standard Co.K875119BIOPSY ATTACH. FOR ADMS ULTRASOUND PROBEAdvanced Diagnostic Medical Systems, Inc.K853104DISPOSABLE, STERILE BIOPSY PUNCHAugust C. Stiefel Research Institute, Inc.K831317BIOPSY ATTACHMENTDiasonics, Inc.

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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