BIPAP AVAPS VENTILATORY SUPPORT SYSTEM— 510(k) K102465
Substantially EquivalentRespironics, Inc.
FDA 510(k) clearance K102465 for BIPAP AVAPS VENTILATORY SUPPORT SYSTEM, Substantially Equivalent on 2011-03-24. Applicant: Respironics, Inc.. Device class: 2.
Clearance details
- Applicant
- Respironics, Inc.
- Product code
- Code MNS
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Murrysville, PA, US
Recent devices under product code MNS
view allMore clearances from Respironics, Inc.
view allAdverse events under product code MNS
product code MNS- Death
- 344
- Injury
- 1,160
- Malfunction
- 8,068
- Total
- 9,572
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 K102465
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 K102465.
Data sourced from openFDA. This site is unofficial and independent of the FDA.