N20 Test
FDA 510(k) K853360 · Erich Jaeger, Inc.
510(k) numberK853360
Submission
- Device name
- N20 Test
- Applicant
- Erich Jaeger, Inc.
Rockford, IL, US - Received
- August 12, 1985
- Decision date
- September 3, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1700
- Specialty
- Anesthesiology
Other 510(k)s with product code CBR
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K112173 | Speacelabs Multigas ModuleCBR · Special | Spacelabs Healthcare | 10/05/2011SE |
| K053599 | Spacelabs Medical Multigas Analyzer Module 91518 and AccessoriesCBR · Special | Spacelabs Medical, Inc. | 04/19/2006SE |
| K954962 | Spacelabs Medical Multigas AnalyzerCBR · Traditional | Spacelabs, Inc. | 05/31/1996SE |
| K904843 | Oscar(Tm) II Capnometer & Pulse OximeterCBR · Traditional | Dalton Instrument Corp. | 04/09/1991SE |
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Questions and answers
When was N20 Test cleared by the FDA?
N20 Test (K853360) received a 510(k) decision of Substantially Equivalent on September 3, 1985, 22 days after the submission was received.
What is the product code of K853360?
The FDA product code is CBR – Analyzer, Gas, Nitrous-Oxide, Gaseous Phase (Anesthetic Conc.), a Class II (moderate risk) device regulated under 21 CFR 868.1700.