FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXICOM-2100
K Number: K921519
·
Decision Oct 23, 1992
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
12
Review Days
206
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Basic Information
- Device Name
- OXICOM-2100
- K Number
- K921519
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Waters Instruments, Inc.
- Date Received
- March 31, 1992
- Decision Date
- October 23, 1992
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- AN
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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Other Clearances by Waters Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K053169 | RM3 RENAL PRESERVATION SYSTEM | Jan 17, 2006 | Substantially Equivalent |
| K042224 | RM3 RENAL PRESERVATION SYSTEM | Oct 22, 2004 | Substantially Equivalent |
| K971571 | RM3 RENAL PRESERVATION SYSTEM--CONTROL UNIT | Jul 29, 1997 | Substantially Equivalent |
| K911207 | OXICOMPLUS | Aug 26, 1991 | Substantially Equivalent |
| K863210 | VELCOM-100 | Nov 26, 1986 | Substantially Equivalent |
| K862161 | OSC-80 OXIMETER | Aug 18, 1986 | Substantially Equivalent |
| K852909 | MVP - 6000 | Nov 14, 1985 | Substantially Equivalent |
| K834408 | TX-2 THERMAL DILUTION CARDIAC OUTPUT | Aug 23, 1984 | Substantially Equivalent |
| K841876 | POLYURETHANE THERMAL DILUTION CATHET | Jul 13, 1984 | Substantially Equivalent |
| K813585 | WATERS ILEOSTOMY VALVE | Apr 9, 1982 | Substantially Equivalent |