MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR— 510(k) K991785
Substantially EquivalentInstrumentation Industries, Inc.
FDA 510(k) clearance K991785 for MANUAL JET VENTILATOR (WITH REGULATOR AND GAUGE), MANUAL JET VENTILATOR (WITHOUT REGULATOR AND GAUGE), MODELS BE 183-SUR, Substantially Equivalent on 1999-08-17. Applicant: Instrumentation Industries, Inc.. Device class: 2.
Clearance details
- Applicant
- Instrumentation Industries, Inc.
- Product code
- Code BTL
- Device class
- Class 2
- Regulation
- 21 CFR 868.5925
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bethel Park, PA, US
Recent devices under product code BTL
view allMore clearances from Instrumentation Industries, Inc.
view allAdverse events under product code BTL
product code BTL- Death
- 8
- Malfunction
- 3,256
- Other
- 1
- Total
- 3,265
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 K991785
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 K991785.
Data sourced from openFDA. This site is unofficial and independent of the FDA.