Engstrom Emma Anesthetic Gas Monitor
FDA 510(k) K802614 · Lkb Instruments, Inc.
510(k) numberK802614
Submission
- Device name
- Engstrom Emma Anesthetic Gas Monitor
- Applicant
- Lkb Instruments, Inc.
Mchenry, IL, US - Received
- October 21, 1980
- Decision date
- January 7, 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
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|---|---|---|---|
| K974903 | Gas Module II, Model 0998-00-0143CBS · Traditional | Datascope Corp. | 03/13/1998SE |
| K953795 | Vitalmax 4100CBS · Traditional | Pace Tech, Inc. | 07/01/1996SE |
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| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K874094 | 1205 Betaplate Liquid Scintillation CounterJJJ · Traditional | 11/04/1987SE |
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| K871303 | Delfia(Tm) Thyroxine (T4) KitCDX · Traditional | 06/17/1987SE |
| K871599 | Delfia(Tm) Hige KitDHB · Traditional | 06/12/1987SE |
| K871644 | Delfia (TM) HTSH KitJLW · Traditional | 05/12/1987SE |
| K864452 | Delfia(Tm) Triiodothyronine (T3) KitCDP · Traditional | 02/02/1987SE |
| K864733 | LKB 2260 MacrotomeIDO · Traditional | 01/05/1987SE |
| K862848 | LKB Ultrobact (TM) Pneumococcus Kit; 2321-110GWC · Traditional | 12/18/1986SE |
| K863422 | Delfia(Tm) Cortisol KitJFT · Traditional | 09/26/1986SE |
| K862044 | Delfia (TM) HCG KitJHJ · Traditional | 07/11/1986SE |
Questions and answers
When was Engstrom Emma Anesthetic Gas Monitor cleared by the FDA?
Engstrom Emma Anesthetic Gas Monitor (K802614) received a 510(k) decision of Substantially Equivalent on January 7, 1981, 78 days after the submission was received.
What is the product code of K802614?
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.