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FDA 510(k)

ETA

K-Number: K883853 · 1988-11-17

ApplicantSevrain-Tech, Inc.
Decision Date1988-11-17
Product CodeLRA
DecisionSubstantially Equivalent

Device Summary

ETA is the device name listed in this FDA 510(k) record. The listed applicant is Sevrain-Tech, Inc.. It received FDA 510(k) clearance on 1988-11-17 under 510(k) number K883853. The device is classified under product code LRA. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ETA?

ETA is a medical device that received FDA 510(k) clearance on 1988-11-17. The listed applicant is Sevrain-Tech, Inc.. The 510(k) number is K883853.

When did ETA receive FDA 510(k) clearance?

ETA received FDA 510(k) clearance on 1988-11-17, under 510(k) number K883853.

Who is the listed applicant for ETA?

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

What is the FDA product code for ETA?

The FDA product code for ETA is LRA.

Related PubMed Literature

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.

PMID: 41209898Evaluation of a Single Knee System: All-Polyethylene Tibia (APT) vs. Metal-Backed Tibia (MBT) in Primary Total Knee Arthroplasty.Cureus ()PMID: 40542709Clinical trial design in FDA submissions for neuromodulation devices, 1960-2023: a systematic review and meta-analysis.Expert review of medical devices ()PMID: 39568744Conflicting interpretations and FDA reputation: the case of post-market surveillance of breast implants.Frontiers in medicine ()PMID: 35106697Interpretation of regulatory factors for 3D printing at hospitals and medical centers, or at the point of care.3D printing in medicine ()

Other records listing Sevrain-Tech, 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.

K884540ETV, ELECTRONIC VISION AID

Related Devices (Code: LRA)

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.

K862471WEARABLE TWENTY-FOUR CHANNEL VIBROTACTILE VOCODERInstitute of LogopedicsK851441TACTICON 1600MedeconK851655TEACHER TMMonargue Intl.K843433KANIEVSKI SENSORY AID OR DEVICESpectro Industries, Inc.K831501TACTIL EAREar Three SystemsK830418TACTAIDAudiological Engineering Corp.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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