FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
STELLAR 300
K Number: K103763
·
Decision Mar 11, 2011
Classifications
1
FEI Numbers
177
Registration Numbers
177
Same Product Code
305
Applicant Total
18
Review Days
78
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Basic Information
- Device Name
- STELLAR 300
- K Number
- K103763
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Larsen & Toubro Limited
- Date Received
- December 23, 2010
- Decision Date
- March 11, 2011
- Product Code
- MWI
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | FDA class 2 | Cardiovascular |
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Other Clearances by Larsen & Toubro Limited
| K Number | Device Name | ||
|---|---|---|---|
| K103686 | STAR 50 N | Mar 15, 2011 | Substantially Equivalent |
| K093017 | STELLAR 300 | Apr 29, 2010 | Substantially Equivalent |
| K092153 | SKYLINE 55, MODEL VER 1 | Nov 20, 2009 | Substantially Equivalent |
| K090172 | STAR 55 MODEL 100 | Jun 5, 2009 | Substantially Equivalent |
| K090443 | PLANET 55, MODEL 100 | Jun 5, 2009 | Substantially Equivalent |
| K082685 | GALAXY 55 | Sep 26, 2008 | Substantially Equivalent |
| K081552 | SKYLINE 55 | Jul 31, 2008 | Substantially Equivalent |
| K080173 | STAR 55 | Feb 8, 2008 | Substantially Equivalent |
| K071472 | PLANET 55 | Sep 21, 2007 | Substantially Equivalent |
| K061816 | GALAXY | Jul 12, 2006 | Substantially Equivalent |