FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NEOGUARD REFLECTOR
K Number: K853794
·
Decision Oct 16, 1985
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
91
Applicant Total
32
Review Days
35
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Basic Information
- Device Name
- NEOGUARD REFLECTOR
- K Number
- K853794
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.5130
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Cas Medical Systems, Inc.
- Date Received
- September 11, 1985
- Decision Date
- October 16, 1985
- Product Code
- FMT
- Advisory Committee
- General Hospital
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| FMT | Warmer, Infant Radiant | FDA class 2 | General Hospital |
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| K140430 | 740 SELECT | Jun 13, 2014 | Substantially Equivalent |
| K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Apr 29, 2014 | Substantially Equivalent |
| K130411 | 740 SELECT | May 29, 2013 | Substantially Equivalent |
| K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER | Apr 11, 2013 | Substantially Equivalent |
| K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER | Jan 26, 2012 | Substantially Equivalent |
| K094030 | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 | Dec 23, 2010 | Substantially Equivalent |