TAP ANTI-SNORING DEVICE— 510(k) K962516

Name: FDA 510(k) clearance K962516
Creator: U.S. Food and Drug Administration
Published: 1996-09-10

Substantially Equivalent

Nellcor Puritan Bennett, Inc.

FDA 510(k) clearance K962516 for TAP ANTI-SNORING DEVICE, Substantially Equivalent on 1996-09-10. Applicant: Nellcor Puritan Bennett, Inc.. Device class: 2.

Clearance details

Applicant: Nellcor Puritan Bennett, Inc.
Product code: Code LRK
Device class: Class 2
Regulation: 21 CFR 872.5570
Advisory panel: Dental
Date received: 1996-06-27
Decision date: 1996-09-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eden Prairie, MN, US

Download summary PDF View on FDA.gov ↗

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K052186 — NELLCOR OXIMAX PULSE OXIMETRY SENSONS (MAX-A, MAX-AL, MAX-N, MAX-I, MAX-P2005-11-10
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Adverse events under product code LRK

product code LRK

Injury: 246
Malfunction: 1,044
Total: 1,290

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.