FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODEL 102 PH METER
K Number: K870811
·
Decision Mar 24, 1987
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
7
Review Days
21
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Basic Information
- Device Name
- MODEL 102 PH METER
- K Number
- K870811
- 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
- March 3, 1987
- Decision Date
- March 24, 1987
- Product Code
- LRI
- 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 |
|---|---|---|---|
| LRI | Ph Meter For Dialysis Hydrogen Ion Concentration | FDA class 2 | Gastroenterology, Urology |
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 |
| 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 |
| K821383 | ECHO, MODEL MM-1000 | Jun 23, 1982 | Substantially Equivalent |