FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECHOCARDIOGRAPHY
K Number: K945163
·
Decision Feb 17, 1995
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
13
Applicant Total
35
Review Days
119
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Basic Information
- Device Name
- ECHOCARDIOGRAPHY
- K Number
- K945163
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 878.4960
- Medical Specialty
- General, Plastic Surgery
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Tri W-G, Inc.
- Date Received
- October 21, 1994
- Decision Date
- February 17, 1995
- Product Code
- LGX
- Advisory Committee
- General, Plastic Surgery
- 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 |
|---|---|---|---|
| LGX | Table, Examination, Medical, Powered | FDA class 1 | General, Plastic Surgery |
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Other Clearances by Tri W-G, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K960196 | TRI W-G, INC TABLE, TILT/EXAM/TREATMENT MODEL 777 | Feb 7, 1996 | Substantially Equivalent |
| K941720 | MODEL 747 AND 747-30 EXAM/TREATMENT TABLE | May 6, 1994 | Substantially Equivalent |
| K936303 | TREATMENT TABLE MODIFICATION | Mar 18, 1994 | Substantially Equivalent |
| K933119 | HI-LO TREATMENT TABLES | Oct 12, 1993 | Substantially Equivalent |
| K932746 | MODEL T4501,T4502,T4503,T4504,T4504 TILT TABLE | Jul 21, 1993 | Substantially Equivalent |
| K930802 | MODELS 642 & 643 TILT EXAM/TREATMENT TABLE | Mar 22, 1993 | Substantially Equivalent |
| K925594 | MDL 29001 MEDI ELEC-MECH TILT EXAM/TREATMENT TABLE | Feb 12, 1993 | Substantially Equivalent |
| K923325 | MODEL 600 MEDICAL TREATMENT TABLE | Jul 21, 1992 | Substantially Equivalent |
| K922980 | 745-M (MAGNUM) | Jul 13, 1992 | Substantially Equivalent |
| K920585 | MAT TABLE, 8100 SERIES MAT PLATFORM | Apr 7, 1992 | Substantially Equivalent |