FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SPM-300
K Number: K130322
·
Decision Nov 15, 2013
Classifications
1
FEI Numbers
92
Registration Numbers
92
Same Product Code
227
Applicant Total
11
Review Days
280
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Basic Information
- Device Name
- SPM-300
- K Number
- K130322
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.1840
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bionet Co., Ltd.
- Date Received
- February 8, 2013
- Decision Date
- November 15, 2013
- Product Code
- BZG
- 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 |
|---|---|---|---|
| BZG | Spirometer, Diagnostic | FDA class 2 | Anesthesiology |
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| K113306 | CARDIO 7 | Jul 16, 2012 | Substantially Equivalent |
| K102767 | CARDIO XP | Jun 3, 2011 | Substantially Equivalent |
| K090895 | EKG-PLUS II SOFTWARE | Aug 26, 2009 | Substantially Equivalent |
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| K043597 | FC 700 FETAL MONITOR | Dec 16, 2005 | Substantially Equivalent |
| K043598 | FC 1400 FETAL MONITOR | Dec 16, 2005 | Substantially Equivalent |