Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr
FDA 510(k) K881004 · Keymed, Inc.
510(k) numberK881004
Submission
- Device name
- Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr
- Applicant
- Keymed, Inc.
Essex Ss2 5qh England, GB - Received
- March 9, 1988
- Decision date
- May 12, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
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| K180711 | FUJIFILM Endoscopic CO2 Regulator GW-100FCX · Special | Fujifilm Corporation | 05/25/2018SE |
| K162332 | Nexcore GI InsufflatorFCX · Traditional | Nexcore Technology, LLC | 09/29/2016SE |
| K133976 | Fujifilm Endoscopic CO2 RegulatorFCX · Traditional | Fujifilm Medical System U.S.A., Inc. | 09/09/2014SE |
| K132192 | Bracco Diagnostics Inc. Protoco, L Touch Colon InsufflatorFCX · Traditional | Bracco Diagnostic, Inc. | 02/14/2014SE |
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| K861821 | Keymed Fiberscope Auto DisinfectorNVE · Traditional | 02/12/1987SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | 12/24/1986SE |
| K862000 | Keymed Flexible Esophageal DilatorsKNQ · Traditional | 08/12/1986SE |
| K860528 | The Keymed Fiberscope Sterilization CaseKCT · Traditional | 07/15/1986SE |
| K861147 | UCS-2, Ultrasonic Cleaning SolutionFLG · Traditional | 06/23/1986SE |
| K860704 | The Keymed Sigmoidoscope Disinfection StandNZA · Traditional | 06/17/1986SE |
| K851149 | Key Med Transendoscopic Vascular Detector TVD-1JAF · Traditional | 11/26/1985SE |
| K854304 | Keymed Office CouchFPO · Traditional | 11/12/1985SE |
Questions and answers
When was Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr cleared by the FDA?
Olympus-Keymed Endoscopic CO2 Regulator, Model Ecr (K881004) received a 510(k) decision of Substantially Equivalent on May 12, 1988, 64 days after the submission was received.
What is the product code of K881004?
The FDA product code is FCX – Insufflator, Automatic Carbon-Dioxide For Endoscope, a Class II (moderate risk) device regulated under 21 CFR 876.1500.