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FDA 510(k)

TRANSDUCER ANTISEPTIC TOWELETTE

K-Number: K812776 · 1982-01-25

ApplicantEcho Laboratories, Inc.
Decision Date1982-01-25
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TRANSDUCER ANTISEPTIC TOWELETTE is the device name listed in this FDA 510(k) record. The listed applicant is Echo Laboratories, Inc.. It received FDA 510(k) clearance on 1982-01-25 under 510(k) number K812776. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TRANSDUCER ANTISEPTIC TOWELETTE?

TRANSDUCER ANTISEPTIC TOWELETTE is a medical device that received FDA 510(k) clearance on 1982-01-25. The listed applicant is Echo Laboratories, Inc.. The 510(k) number is K812776.

When did TRANSDUCER ANTISEPTIC TOWELETTE receive FDA 510(k) clearance?

TRANSDUCER ANTISEPTIC TOWELETTE received FDA 510(k) clearance on 1982-01-25, under 510(k) number K812776.

Who is the listed applicant for TRANSDUCER ANTISEPTIC TOWELETTE?

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

What is the FDA product code for TRANSDUCER ANTISEPTIC TOWELETTE?

The FDA product code for TRANSDUCER ANTISEPTIC TOWELETTE is ITX.

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Other records listing Echo Laboratories, 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.

K812606SECTORTACK781649ULTRASONIC TRANSDUCERSK781631ECHO-OIL

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

Official Source

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