FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MS PAED-BABY BODY
K Number: K023796
·
Decision Mar 3, 2003
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
10
Applicant Total
5
Review Days
110
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Basic Information
- Device Name
- MS PAED-BABY BODY
- K Number
- K023796
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 868.1750
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Erich Jaeger GmbH
- Date Received
- November 13, 2002
- Decision Date
- March 3, 2003
- Product Code
- CCM
- 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 |
|---|---|---|---|
| CCM | Plethysmograph, Pressure | FDA class 2 | Anesthesiology |
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Other Clearances by Erich Jaeger GmbH
| K Number | Device Name | ||
|---|---|---|---|
| K023120 | OXYCON MOBILE | Nov 12, 2003 | Substantially Equivalent |
| K021138 | SLEEPSCREEN/APNOESCREEN CARDIO | Feb 12, 2003 | Substantially Equivalent |
| K001502 | AEROSOL PROVOCATION SYSTEM APS PRO, MODEL APS PRO | Jul 12, 2000 | Substantially Equivalent |
| K000648 | SPIRO PRO | Mar 29, 2000 | Substantially Equivalent |