V*CARE MANUAL RESUSCITATOR, CAT#VR-1000— 510(k) K913900
Substantially EquivalentVentlab Corp.
FDA 510(k) clearance K913900 for V*CARE MANUAL RESUSCITATOR, CAT#VR-1000, Substantially Equivalent on 1992-01-07. Applicant: Ventlab Corp.. Device class: 2.
Clearance details
- Applicant
- Ventlab Corp.
- 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
- Bound Brook, NJ, US
Recent devices under product code BTM
view allMore clearances from Ventlab Corp.
view all- K120118 — VENTLAB PRESSURECHEK DISOSABLE COLUMN MANOMETER
- K102674 — CUFF SENTRY
- K093617 — VENTLAB 6000 SERIES HUMIDIFIER
- K093525 — ACE/STATCHECK II CO2 INDICATOR, ACE/STATCHECK II CO2 INDICATOR ARM ASSEMBY ADULT STATCHECK RESUSCITATOR WITH ACE/STATCHE
- K090840 — VENTLAB 5000 SERIES NEBULIZER ASSEMBLY, CUP, CUP W/ MASK, CUP W/ FITSALL CONN.
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.