FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDELA BATTERY OPERATED BREAST PUMP
K Number: K901344
·
Decision Aug 6, 1990
Classifications
1
FEI Numbers
117
Registration Numbers
117
Same Product Code
243
Applicant Total
19
Review Days
137
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Basic Information
- Device Name
- MEDELA BATTERY OPERATED BREAST PUMP
- K Number
- K901344
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.5160
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Applicant
- Medela, Inc.
- Date Received
- March 22, 1990
- Decision Date
- August 6, 1990
- 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 Medela, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K161811 | Medela Low Dose Enteral Syringe | Feb 15, 2017 | Substantially Equivalent |
| K161725 | Sonata Breastpump Deluxe, Sonata Warranty Breastpump, Double pumping Tubing Kit, retail, Connector spare parts kit, Silicone Membrane, retail, Power Adaptor, retail | Oct 28, 2016 | Substantially Equivalent |
| K031614 | MEDELA PUMP IN STYLE ADVANCED BREAST PUMP | Jun 6, 2003 | Substantially Equivalent |
| K020518 | MEDELA SYMPHONY BREAST PUMP, MODEL 024 | Mar 7, 2002 | Substantially Equivalent |
| K984589 | PHOTOTHERAPY LAMP | Apr 20, 1999 | Substantially Equivalent |
| K983552 | BASIC, MEDIAN, DOMINANT, AND VARIO | Jan 7, 1999 | Substantially Equivalent |
| K962612 | BILIBED PHOTOTHERAPY LAMP | Dec 12, 1996 | Substantially Equivalent |
| K950750 | MEDELAS BREAST PUMP | Oct 16, 1995 | Substantially Equivalent |
| K952034 | MEDELA'S FOOT PUMP | Sep 12, 1995 | Substantially Equivalent |
| K923577 | BREAST SHELLS | Jan 22, 1993 | Substantially Equivalent |