FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
K Number: K892885
·
Decision Oct 6, 1989
Classifications
1
FEI Numbers
47
Registration Numbers
47
Same Product Code
99
Applicant Total
17
Review Days
170
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Basic Information
- Device Name
- RESUBMITTED RD1000 NEOPUFF INFANT RESUSCITATOR
- K Number
- K892885
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5925
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Fisher & Paykel Electronics , Ltd.
- Date Received
- April 19, 1989
- Decision Date
- October 6, 1989
- Product Code
- BTL
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BTL | Ventilator, Emergency, Powered (Resuscitator) | FDA class 2 | Anesthesiology |
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