TELSTAR PREWIRE SERIES— 510(k) K871731

Name: FDA 510(k) clearance K871731
Creator: U.S. Food and Drug Administration
Published: 1987-10-27

Substantially Equivalent

Telstar Electronics, Inc.

FDA 510(k) clearance K871731 for TELSTAR PREWIRE SERIES, Substantially Equivalent on 1987-10-27. Applicant: Telstar Electronics, Inc.. Device class: 2.

Clearance details

Applicant: Telstar Electronics, Inc.
Product code: Code LRS
Device class: Class 2
Regulation: 21 CFR 880.5200
Advisory panel: General Hospital
Date received: 1987-05-05
Decision date: 1987-10-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Longwood, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Telstar Electronics, Inc.

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K892457 — TELSTAR MODEL 1/3 ITE HEARING AID1989-06-06
K892458 — TELSTAR MODEL F ITE HEARING AID1989-06-06
K892459 — TELSTAR MODEL C ITE HEARING AID1989-06-06
K892460 — TELSTAR MODEL PP ITE HEARING AID1989-06-06
K873210 — TELSTAR MODEL PP1987-09-29

Adverse events under product code LRS

product code LRS

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.