FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
K Number: K874378
·
Decision Dec 30, 1987
Classifications
1
FEI Numbers
420
Registration Numbers
420
Same Product Code
1186
Applicant Total
50
Review Days
65
Basic Information
- Device Name
- DINAMAP VITAL SIGNS MONITOR, MODEL 8100T
- K Number
- K874378
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1130
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- CRITIKON COMPANY,LLC
- Date Received
- October 26, 1987
- Decision Date
- December 30, 1987
- Product Code
- DXN
- 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 |
|---|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K982342 | DINAMAP MPS SELECT PORTABLE MONITOR | Aug 14, 1998 | Substantially Equivalent |
| K943709 | DINAMAP PLUS VITAL SIGNS MONOITOR | Jun 16, 1995 | Substantially Equivalent |
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| K933404 | CRITIKON CENTRAL STATIN MONITOR | Feb 9, 1994 | Substantially Equivalent |
| K933050 | CHANGES TO PROTECTIV(TM) & JELCO(TM) WINGED CATH | Dec 14, 1993 | Substantially Equivalent |
| K915697 | CRITIKON VITAL SIGNS MODULE | Jul 1, 1993 | Substantially Equivalent |
| K921295 | INTRAVENOUS CATHETERS MODIFICATIONS | May 17, 1993 | Substantially Equivalent |
| K912188 | DINAMAP PLUS PHYSIOLOGICAL MONITOR MODEL 8700 | Dec 4, 1991 | Substantially Equivalent |