FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ECHO, MODEL MM-1000
K Number: K821383
·
Decision Jun 23, 1982
Classifications
1
FEI Numbers
7
Registration Numbers
7
Same Product Code
56
Applicant Total
7
Review Days
44
Basic Information
- Device Name
- ECHO, MODEL MM-1000
- K Number
- K821383
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5820
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- MESA MEDICAL, INC.
- Date Received
- May 10, 1982
- Decision Date
- June 23, 1982
- Product Code
- LIF
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- GU
- 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 |
|---|---|---|---|
| LIF | Dialyzer Reprocessing System | FDA class 2 | Gastroenterology, Urology |
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Other Clearances by MESA MEDICAL, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K925210 | 90DX MULTITEST METER, MODIFICATION | Jan 25, 1994 | Substantially Equivalent |
| K882032 | MODEL 90DX MULTITEST METER | Aug 11, 1988 | Substantially Equivalent |
| K870811 | MODEL 102 PH METER | Mar 24, 1987 | Substantially Equivalent |
| K852749 | RECOMMENDED ALTERNATIVE DIALYZER DISINFECTANT | Sep 10, 1985 | Substantially Equivalent |
| K843520 | WAREXIN RECOMMENDED ALTERNATIVE DIALYZ | Oct 4, 1984 | Substantially Equivalent |
| K834447 | ECHO MM1000 | Mar 23, 1984 | Substantially Equivalent |