FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIATEK 500
K Number: K790416
·
Decision Apr 10, 1979
Classifications
1
FEI Numbers
488
Registration Numbers
488
Same Product Code
797
Applicant Total
15
Review Days
41
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Basic Information
- Device Name
- DIATEK 500
- K Number
- K790416
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 880.2910
- Medical Specialty
- General Hospital
- Decision
- Substantially Equivalent
- Applicant
- Diatek, Inc.
- Date Received
- February 28, 1979
- Decision Date
- April 10, 1979
- Product Code
- FLL
- Advisory Committee
- General Hospital
- 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 |
|---|---|---|---|
| FLL | Continuous Measurement Thermometer | FDA class 2 | General Hospital |
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Other Clearances by Diatek, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020430 | DIATEK CONNECTOR ASSEMBLY REPLACEMENT KIT (CARK) | May 9, 2002 | Substantially Equivalent |
| K010399 | DIATEK CANNON-CATH #CC2400, CC2800, CC3200, CC3600,CC5500. CC2400PC, CC2800PC, CC3200PC(32 CM), CC3200PC(36 CM) | Aug 14, 2001 | Substantially Equivalent |
| K895703 | DIATEK MODEL 700 THERMOMETER | Dec 7, 1989 | Substantially Equivalent |
| K872178 | MODIFICATION TO ARKIVE(TM) | Jan 27, 1988 | Substantially Equivalent |
| K862085 | ARKIVE (TM) | Jan 12, 1987 | Substantially Equivalent |
| K841827 | ENTEROPORT NUTRITION PUMP | Jul 27, 1984 | Substantially Equivalent |
| K841859 | SECURA SET | Jul 3, 1984 | Substantially Equivalent |
| K833568 | DIATEK 600 THERMOMETER SYSTEM | Jan 10, 1984 | Substantially Equivalent |
| K830565 | SECURA SET SECONDARY ADMIN. SET | Mar 9, 1983 | Substantially Equivalent |
| K830377 | SECURA SET PRIMARY ADMIN. SET | Mar 1, 1983 | Substantially Equivalent |