HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR— 510(k) K964719
Substantially EquivalentHudson Respiratory Care, Inc.
FDA 510(k) clearance K964719 for HUDSON RCI LIFESAVER SINGLE PATIENT USE MANUAL RESUSCITATOR, Substantially Equivalent on 1997-02-21. Applicant: Hudson Respiratory Care, Inc.. Device class: 2.
Clearance details
- Applicant
- Hudson Respiratory Care, Inc.
- Product code
- Code BTM
- Device class
- Class 2
- Regulation
- 21 CFR 868.5915
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Temecula, CA, US
Recent devices under product code BTM
view allMore clearances from Hudson Respiratory Care, Inc.
view allAdverse events under product code BTM
product code BTM- Death
- 19
- Other
- 2
- Total
- 21
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 K964719
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 K964719.
Data sourced from openFDA. This site is unofficial and independent of the FDA.