FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
K Number: K022933
·
Decision Dec 2, 2002
Classifications
1
FEI Numbers
114
Registration Numbers
114
Same Product Code
202
Applicant Total
8
Review Days
89
Basic Information
- Device Name
- EVENFLO COMFORT SELECT AUTO-CYCLE BREAST PUMP KIT
- K Number
- K022933
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- EVENFLO COMPANY, INC.
- Date Received
- September 4, 2002
- Decision Date
- December 2, 2002
- Product Code
- HGX
- Advisory Committee
- Obstetrics/Gynecology
- Review Advisory Committee
- OB
- 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 |
|---|---|---|---|
| HGX | Pump, Breast, Powered | FDA class 2 | Obstetrics/Gynecology |
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Other Clearances by EVENFLO COMPANY, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K102600 | SIMPLYGO BREAST PUMP | Dec 22, 2010 | Substantially Equivalent |
| K100435 | AMEDA PLATINUM BREAST PUMP | May 28, 2010 | Substantially Equivalent |
| K092770 | SIMPLYGO HANDS FREE BREAST PUMP | Oct 9, 2009 | Substantially Equivalent |
| K082307 | EVENFLO COMFORT SELECT PERFORMANCE BREAST PUMP KIT | Sep 11, 2008 | Substantially Equivalent |
| K053493 | BERRY FRUITY TEETHER | Feb 22, 2006 | Substantially Equivalent |
| K052909 | EVENFLO ELAN BREAST PUMP | Nov 1, 2005 | Substantially Equivalent |
| K013226 | EVENFLO COMFORT EASE MANUAL BREAST PUMP KIT | Dec 20, 2001 | Substantially Equivalent |