RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR— 510(k) K892885
Substantially EquivalentFisher & Paykel Electronics , Ltd.
FDA 510(k) clearance K892885 for RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR, Substantially Equivalent on 1989-10-06. Applicant: Fisher & Paykel Electronics , Ltd.. Device class: 2.
Clearance details
- Applicant
- Fisher & Paykel Electronics , Ltd.
- 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
- Auckland, New Zealand, NZ
Recent devices under product code BTL
view allMore clearances from Fisher & Paykel Electronics , Ltd.
view all- K973161 — CPAP HUMIDIFIER (HC 200)
- K972885 — SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970
- K971695 — SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER
- K971461 — SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
- K970432 — INFANT RADIANT WARMER - MODELS IW910 AND IW920
Adverse 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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.