FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO ARKIVE(TM)
K Number: K872178
·
Decision Jan 27, 1988
Classifications
1
FEI Numbers
31
Registration Numbers
31
Same Product Code
186
Applicant Total
15
Review Days
233
Basic Information
- Device Name
- MODIFICATION TO ARKIVE(TM)
- K Number
- K872178
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5160
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- DIATEK, INC.
- Date Received
- June 8, 1987
- Decision Date
- January 27, 1988
- Product Code
- BSZ
- Advisory Committee
- Anesthesiology
- 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 |
|---|---|---|---|
| BSZ | Gas-Machine, Anesthesia | FDA class 2 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BSZ), ordered by most recent decision date.
Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-700i and related 610i, 620i, 630i series enabled to retrofit RFID features); Codonics Safe Labeling System-Point of Care Station (PCS) (SLS-1, SLS XXX, Multiple Models Pending Configuration)
FDA 510(k)
FDA Class 2
·Anesthesiology
Atlan
FDA 510(k)
FDA Class 2
·Anesthesiology
Carestation 750/750c
FDA 510(k)
FDA Class 2
·Anesthesiology
A8, A9 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
A5 Anesthesia System
FDA 510(k)
FDA Class 2
·Anesthesiology
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 |
| 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 |
| K830355 | SECURA IV VOLUMETRIC INFUSION PUMP | Mar 1, 1983 | Substantially Equivalent |