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FDA 510(k)

SONOCARE

K-Number: K844034 · 1985-01-23

ApplicantEcho Ultrasound
Decision Date1985-01-23
Product CodeDYO
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SONOCARE is the device name listed in this FDA 510(k) record. The listed applicant is Echo Ultrasound. It received FDA 510(k) clearance on 1985-01-23 under 510(k) number K844034. The device is classified under product code DYO. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONOCARE?

SONOCARE is a medical device that received FDA 510(k) clearance on 1985-01-23. The listed applicant is Echo Ultrasound. The 510(k) number is K844034.

When did SONOCARE receive FDA 510(k) clearance?

SONOCARE received FDA 510(k) clearance on 1985-01-23, under 510(k) number K844034.

Who is the listed applicant for SONOCARE?

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 SONOCARE?

The FDA product code for SONOCARE is DYO.

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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 COLUMNK893225COUPLANT WARMING DEVICEK872519STERILIZED OMNI GELK844120ULTRASONIC SCANNER CALIBRATION & TEST OBJECTS

Related Devices (Code: DYO)

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.

K935152DENTAURUM DENTAFORM BANDS, DENTAURUM STANDARDDentauraum, Inc.K931980STAINLESS STEEL ORTHODONTIC PRODUCTSOrtho Organizers, 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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