HEEL SNUGGLER, MODEL 99047— 510(k) K040044

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K040044 for HEEL SNUGGLER, MODEL 99047, Substantially Equivalent on 2004-01-27. Applicant: Respironics, Inc.. Device class: 1.

Clearance details

Applicant: Respironics, Inc.
Product code: Code MPO
Device class: Class 1
Regulation: 21 CFR 890.5710
Advisory panel: Physical Medicine
Date received: 2004-01-12
Decision date: 2004-01-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K040044

K-number listed on FDA's recall record

Z-0507-2022 — Heel Snuggler, Reference # 989805603411 99047Class II·Ongoing·Philips North America Llc·20211129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K040044.

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