AS/3(TM) Anesthesia Monitor Syst Interface Board
FDA 510(k) K935477 · Datex Division Instrumentarium Corp.
510(k) numberK935477
Submission
- Device name
- AS/3(TM) Anesthesia Monitor Syst Interface Board
- Applicant
- Datex Division Instrumentarium Corp.
Helsinki, Finland, FI - Received
- November 15, 1993
- Decision date
- August 1, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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More from Southmedic, Inc.
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|---|---|---|
| K953175 | AS/3 Estpr ModuleMLD · Traditional | 02/06/1997SE |
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| K943458 | AS/3 Airway ModuleCBS · Traditional | 02/14/1995SE |
| K945234 | AS/3 Memory Module, M0MEMBSZ · Traditional | 01/27/1995SE |
| K933156 | Datex AS/3 Patient MonitorDPS · Traditional | 12/30/1994SE |
| K933285 | Datex AS/3 TM Anaesthesia MonitorBSZ · Traditional | 11/14/1994SE |
| K943456 | AS/3 Nellcor Compatible Saturation Moodule, M-NsatDQA · Traditional | 10/17/1994SE |
| K923172 | Anaesthesia Record KeeperBSZ · Traditional | 08/09/1994SE |
| K943457 | AS/3 Pressure Temperature Module, M-PtDSK · Traditional | 07/27/1994SE |
| K933284 | AS/3 TM NetworkCCK · Traditional | 07/11/1994SE |
Questions and answers
When was AS/3(TM) Anesthesia Monitor Syst Interface Board cleared by the FDA?
AS/3(TM) Anesthesia Monitor Syst Interface Board (K935477) received a 510(k) decision of Substantially Equivalent on August 1, 1994, 259 days after the submission was received.
What is the product code of K935477?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.