IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES— 510(k) K905236
Substantially EquivalentPercussionaire Corp.
FDA 510(k) clearance K905236 for IPV PERCUSSIONATOR FAMILY & RELATED ACCESSORIES, Substantially Equivalent on 1991-04-18. Applicant: Percussionaire Corp.. Device class: 2.
Clearance details
- Applicant
- Percussionaire Corp.
- Product code
- Code NHJ
- Device class
- Class 2
- Regulation
- 21 CFR 868.5905
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sandpoint, ID, US
Recent devices under product code NHJ
view allMore clearances from Percussionaire Corp.
view allAdverse events under product code NHJ
product code NHJ- Death
- 7
- Total
- 7
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 K905236
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 K905236.
Data sourced from openFDA. This site is unofficial and independent of the FDA.