Amer Profile Miller Laryngoscope Blades, Modified
FDA 510(k) K914741 · Eastmed Enterprises, Inc.
510(k) numberK914741
Submission
- Device name
- Amer Profile Miller Laryngoscope Blades, Modified
- Applicant
- Eastmed Enterprises, Inc.
Marlton, NJ, US - Received
- October 18, 1991
- Decision date
- February 3, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
Other 510(k)s with product code CCW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K191602 | APA Oxy BladeCCW · Traditional | Venner Medical (Singapore) Pte, Ltd. | 08/02/2019SE |
| 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 |
| K121378 | Airtraq SP Airtraq AvantCCW · Traditional | Prodol Meditec , Ltd. | 06/21/2012SE |
| K063477 | Novamed MRI Conditional Laryngoscope SetCCW · Traditional | Novamed, LLC | 02/09/2007SE |
| K062523 | Tru-Mr Laryngoscope SetCCW · Traditional | Truphatek International, Ltd. | 11/17/2006SE |
| K062231 | MR Fiber Optic Intubating Laryngoscope Handle, Standard, Model 310001CCW · Special | Minrad, Inc. | 08/31/2006SE |
| K062230 | MR Fiber Optic Intubating Laryngoscope Handle, Short, Model 310002CCW · Special | Minrad, Inc. | 08/31/2006SE |
| K041852 | MR Tested Fiber Optic Short Laryngoscope Handle, Model 310002CCW · Traditional | Minrad, Inc. | 11/15/2004SE |
| K984101 | FlexibladeCCW · Traditional | Arco Medic , Ltd. | 09/03/1999SE |
More from Arco Medic , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K922019 | Laryngoscope RigidCCW · Traditional | 01/26/1993SE |
| K921128 | Endotracheal Tube StyletBSR · Traditional | 06/02/1992SE |
| K903618 | Robertazzi Nasopharyngeal AirwayBTQ · Traditional | 01/08/1991SE |
| K901489 | Macintosh Laryngoscope Blades (American Profile)CCW · Traditional | 04/10/1990SE |
| K890342 | Airways (Guedel, Berman & Nasopharyngeal Types)BTO · Traditional | 04/27/1989SE |
| K884584 | Tongue Seizing Forceps with & Without Rubber PadsBWB · Traditional | 11/14/1988SE |
| K884073 | Laryngoscope Blade (Robertshaw Style)CCW · Traditional | 10/13/1988SE |
| K884072 | 15 Millimeter Male and Female AdaptersCAI · Traditional | 10/07/1988SE |
| K882433 | Laryngoscope RigidCCW · Traditional | 09/02/1988SE |
| K882434 | Mask, Gas, AnestheticBSJ · Traditional | 06/30/1988SE |
Questions and answers
When was Amer Profile Miller Laryngoscope Blades, Modified cleared by the FDA?
Amer Profile Miller Laryngoscope Blades, Modified (K914741) received a 510(k) decision of Substantially Equivalent on February 3, 1992, 108 days after the submission was received.
What is the product code of K914741?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.