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FDA 510(k)

COUPLANT WARMING DEVICE

K-Number: K893225 · 1989-10-12

ApplicantEcho Ultrasound
Decision Date1989-10-12
Product CodeIYO
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

COUPLANT WARMING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Echo Ultrasound. It received FDA 510(k) clearance on 1989-10-12 under 510(k) number K893225. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COUPLANT WARMING DEVICE?

COUPLANT WARMING DEVICE is a medical device that received FDA 510(k) clearance on 1989-10-12. The listed applicant is Echo Ultrasound. The 510(k) number is K893225.

When did COUPLANT WARMING DEVICE receive FDA 510(k) clearance?

COUPLANT WARMING DEVICE received FDA 510(k) clearance on 1989-10-12, under 510(k) number K893225.

Who is the listed applicant for COUPLANT WARMING DEVICE?

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

What is the FDA product code for COUPLANT WARMING DEVICE?

The FDA product code for COUPLANT WARMING DEVICE is IYO.

Related Clinical Trials

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.

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Other records listing Echo Ultrasound 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.

K924054PHONOCARDIOGRAPHK903414TRANSESOPHAGEAL PROBE HOLDER & DISINFECTING COLUMNK872519STERILIZED OMNI GELK844120ULTRASONIC SCANNER CALIBRATION & TEST OBJECTSK844034SONOCARE

Related Devices (Code: IYO)

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.

K260313MD-6000S Bladder ScannerMEDA Co., Ltd.K253452Accuro 3SRivanna Medical, Inc.K260190ARTHURROPCA ApSK252237EdgeFlow UW20Edgecare, Inc.K254021Accuro XVRivanna Medical, Inc.K253898QT Scanner 2000 Model AQT Imaging Holdings, 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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