Sara
FDA 510(k) K810585 · Allied Healthcare Products, Inc.
510(k) numberK810585
Submission
- Device name
- Sara
- Applicant
- Allied Healthcare Products, Inc.
Mchenry, IL, US - Received
- March 4, 1981
- Decision date
- March 24, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBS – Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1620
- Specialty
- Anesthesiology
Other 510(k)s with product code CBS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974903 | Gas Module II, Model 0998-00-0143CBS · Traditional | Datascope Corp. | 03/13/1998SE |
| K953795 | Vitalmax 4100CBS · Traditional | Pace Tech, Inc. | 07/01/1996SE |
| K960490 | AS/3 Compact Airway Module M-CaiovCBS · Traditional | Datex Medical Instrumentation, Inc. | 05/03/1996SE |
| K951366 | Riken Gas Indicator (3 Models, 1806H, 1802D, IF-18)CBS · Traditional | Riken Keiki Co., Ltd. | 08/02/1995SE |
| K950101 | Rams (Random Access Mass Spectrometer) M-200 Respiratory Gas MonitorCBS · Traditional | Marquette Electronics, Inc. | 03/21/1995SE |
| K943458 | AS/3 Airway ModuleCBS · Traditional | Datex Division Instrumentarium Corp. | 02/14/1995SE |
| K942737 | Poet Iq with Five Agent CapabilityCBS · Traditional | Criticare Systems, Inc. | 02/09/1995SE |
| K932389 | 8100 Anesthetic Agent MonitorCBS · Traditional | Biochem International, Inc. | 12/03/1993SE |
| K905754 | Capnomac Ultima Anesthesia MonitorCBS · Traditional | Datex Division Instrumentarium Corp. | 06/17/1991SE |
| K896629 | Nellcor Model N-2500 Anesthesia Safety MonitorCBS · Traditional | Nellcor, Inc. | 02/12/1990SE |
More from Nellcor, Inc.
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|---|---|---|
| K131098 | Emergency Portable VentilatorBTL · Traditional | 04/09/2014SE |
| K132021 | Ahp 300, Emergency Portable VentilatorBTL · Traditional | 04/02/2014SE |
| K090356 | Emergency Portable Ventilator, Model EPV200BTL · Traditional | 05/20/2009SE |
| K083507 | Battery Pack for MCV100 and MCV200 Emergency VentilatorsBTL · Traditional | 05/18/2009SE |
| K083385 | Mass Casualty Ventilators, Models: MCV200 and MCV200-BBTL · Traditional | 05/14/2009SE |
| K080063 | Mass Casualty Ventilator, Model MCV100BTL · Traditional | 08/15/2008SE |
| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | 03/06/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 01/31/2008SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | 05/03/2007SE |
Questions and answers
When was Sara cleared by the FDA?
Sara (K810585) received a 510(k) decision of Substantially Equivalent on March 24, 1981, 20 days after the submission was received.
What is the product code of K810585?
The FDA product code is CBS – Analyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1620.