Orotracheal Intubation Endoscope
FDA 510(k) K801452 · Olympus Corp.
510(k) numberK801452
Submission
- Device name
- Orotracheal Intubation Endoscope
- Applicant
- Olympus Corp.
Walker, MI, US - Received
- June 23, 1980
- Decision date
- July 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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| K163412 | Girgis Scope Video 200 Double Bladed Laryngoscope (GSV200.DBL)CCW · Traditional | Girgis Scope, LLC | 06/22/2017SE |
| K140951 | Yeescope LaryngoscopesCCW · Traditional | Yeescope Pty. , Ltd. | 11/10/2014SE |
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| K063477 | Novamed MRI Conditional Laryngoscope SetCCW · Traditional | Novamed, LLC | 02/09/2007SE |
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| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | Minrad, Inc. | 08/31/2006SE |
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| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
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Questions and answers
When was Orotracheal Intubation Endoscope cleared by the FDA?
Orotracheal Intubation Endoscope (K801452) received a 510(k) decision of Substantially Equivalent on July 14, 1980, 21 days after the submission was received.
What is the product code of K801452?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.