FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇿 New Zealand
CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
K Number: K924234
·
Decision May 27, 1993
Classifications
1
FEI Numbers
53
Registration Numbers
53
Same Product Code
28
Applicant Total
17
Review Days
276
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Basic Information
- Device Name
- CONS. CURRENT PERIPH. NERVE LOC. NS232,NS262,NS272
- K Number
- K924234
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2775
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Fisher & Paykel Electronics , Ltd.
- Date Received
- August 24, 1992
- Decision Date
- May 27, 1993
- Product Code
- KOI
- 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 |
|---|---|---|---|
| KOI | Stimulator, Nerve, Peripheral, Electric | FDA class 2 | Anesthesiology |
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|---|---|---|---|
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| K971695 | SERVO-CONTROL COSYCOT INFANT WARMER, MANUAL-CONTROL COSYCOT INFANT WARMER | Jul 28, 1997 | Substantially Equivalent |
| K971461 | SERVO-CONTROL WALL-MOUNT INFANT WARMER(IW980)/MANUAL-CONTROL WALL-MOUNT INFANT WARMER(IW990) | Jul 16, 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 |
| K915460 | HEATED RESPIRATORY HUMIDIFIER HC100 | Jan 15, 1993 | Substantially Equivalent |