OPTICHAMBER DIAMOND VALVED HOLDING CHAMBER— 510(k) K110293
Substantially EquivalentRespironics 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
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More clearances from Respironics New Jersey, Inc.
view allAdverse 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 recordMatched 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.