OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER— 510(k) K110293

Substantially Equivalent

Respironics New Jersey, Inc.

FDA 510(k) clearance K110293 for OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER, Substantially Equivalent on 2011-08-09. Applicant: Respironics New Jersey, Inc.. Device class: 2.

Clearance details

Applicant
Respironics New Jersey, Inc.
Product code
Code NVP
Device class
Class 2
Regulation
21 CFR 868.5630
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Parsippany, NJ, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code NVP

product code NVP
Other
1
Total
1

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 K110293

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 K110293.

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