FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
K Number: K971461
·
Decision Jul 16, 1997
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
17
Review Days
86
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Basic Information
- Device Name
- SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990)
- K Number
- K971461
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Fisher & Paykel Electronics , Ltd.
- Date Received
- April 21, 1997
- Decision Date
- July 16, 1997
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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Other Clearances by Fisher & Paykel Electronics , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K973161 | CPAP HUMIDIFIER (HC 200) | Jul 10, 1998 | Substantially Equivalent |
| K972885 | SERVO-CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW960, MANUAL CONTROL WALL-MOUNT COSYCOT INFANT WARMER MODEL IW970 | Oct 30, 1997 | Substantially Equivalent |
| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | Jul 28, 1997 | Substantially Equivalent |
| K970432 | INFANT RADIANT WARMER - MODELS IW910 AND IW920 | May 7, 1997 | Substantially Equivalent |
| K953392 | HC500 SERVO-CONTROLLED HEATED RESPIRATORY HUMIDIFIER (& ACCESSORIES) | Mar 12, 1996 | Substantially Equivalent |
| K953711 | AIR ENTRAINER 900RT008 | Nov 8, 1995 | Substantially Equivalent |
| K953949 | HUMIDIFIER & ACCESSORIES | Oct 16, 1995 | Substantially Equivalent |
| K934140 | MR290 HUMIDIFICATION CHAMBER SINGLE USE | Jan 24, 1994 | Substantially Equivalent |
| K924234 | CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272 | May 27, 1993 | Substantially Equivalent |
| K915460 | HEATED RESPIRATORY HUMIDIFIER HC100 | Jan 15, 1993 | Substantially Equivalent |