FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RS BIOTECH GALAXY 'R' CO2 INCUBATOR
K Number: K003184
·
Decision Nov 20, 2000
Classifications
1
FEI Numbers
24
Registration Numbers
24
Same Product Code
45
Applicant Total
5
Review Days
40
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Basic Information
- Device Name
- RS BIOTECH GALAXY 'R' CO2 INCUBATOR
- K Number
- K003184
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 884.6120
- Medical Specialty
- Obstetrics/Gynecology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zander Medical Supplies, Inc.
- Date Received
- October 11, 2000
- Decision Date
- November 20, 2000
- Product Code
- MQG
- 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 |
|---|---|---|---|
| MQG | Accessory, Assisted Reproduction | FDA class 2 | Obstetrics/Gynecology |
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