DeviceClearance

REMSTAR AUTO A-FLEX HT— 510(k) K131982

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K131982 for REMSTAR AUTO A-FLEX HT, Substantially Equivalent on 2013-10-18. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant
Respironics, Inc.
Product code
Code BZD
Device class
Class 2
Regulation
21 CFR 868.5905
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Murrysville, PA, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code BZD

product code BZD
Death
4,440
Injury
53,099
Malfunction
213,222
Other
17
Total
270,778

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

Recalls naming K131982

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K131982.

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