Amt Endotracheal Tube Bridle Retention System
FDA 510(k) K140097 · Applied Medical Technology, Inc.
510(k) numberK140097
Submission
- Device name
- Amt Endotracheal Tube Bridle Retention System
- Applicant
- Applied Medical Technology, Inc.
Brecksville, OH, US - Received
- January 14, 2014
- Decision date
- September 24, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CBH – Device, Fixation, Tracheal Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5770
- Specialty
- Anesthesiology
Other 510(k)s with product code CBH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K964399 | Dale Endotracheal Tube Holder 270/280CBH · Traditional | Dale Medical Products, Inc. | 01/28/1997SE |
| K942529 | Hci Tube StabilizerCBH · Traditional | Health Care Contracts, Inc. | 06/14/1995SE |
| K951491 | Dale Tracheostomy Tube Holder with Trach Mask Attachment TabsCBH · Traditional | Dale Medical Products, Inc. | 04/24/1995SE |
| K950930 | Trache-TiteCBH · Traditional | The Varner Group, Inc. | 03/22/1995SE |
| K950318 | Flex BlueCBH · Traditional | King Systems Corp. | 02/13/1995SE |
| K942395 | Endotracheal Tube HolderCBH · Traditional | S.T.I. Medical Products Corp. | 06/30/1994SE |
| K934288 | Holde.T. Endotracheal Tube Stabilization BarCBH · Traditional | Neo-Tech, Inc. | 06/09/1994SE |
| K942016 | Trach Tie, Ventilator Tubing HolderCBH · Traditional | Garrett Medical Products | 05/24/1994SE |
| K941384 | TrakeezCBH · Traditional | Ergomed, Inc. | 04/19/1994SE |
| K940448 | Netoh Endotracheal Tube HolderCBH · Traditional | Medical Accessory Services, Inc. | 02/22/1994SE |
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Questions and answers
When was Amt Endotracheal Tube Bridle Retention System cleared by the FDA?
Amt Endotracheal Tube Bridle Retention System (K140097) received a 510(k) decision of Substantially Equivalent on September 24, 2014, 253 days after the submission was received.
What is the product code of K140097?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.