Baby E.T. Tape(Tm)
FDA 510(k) K871560 · B&B Medical Technologies, Inc.
510(k) numberK871560
Submission
- Device name
- Baby E.T. Tape(Tm)
- Applicant
- B&B Medical Technologies, Inc.
Rancho Cordova, CA, US - Received
- April 22, 1987
- Decision date
- May 22, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K140097 | Amt Endotracheal Tube Bridle Retention SystemCBH · Traditional | Applied Medical Technology, Inc. | 09/24/2014SE |
| 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 |
More from Ergomed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K030396 | Omni~Neb; Omni~MaxCAF · Traditional | 05/07/2004SE |
| K980407 | Hope NebulizerCAF · Traditional | 05/27/1998SE |
| K960663 | Universal Bite BlockJXL · Traditional | 05/17/1996SE |
| K945816 | Quick-LockBTR · Traditional | 01/13/1995SE |
| K944324 | Sure-Lock Ventilator Tubing HolderBTR · Traditional | 11/04/1994SE |
| K935171 | StabiltrachCBH · Traditional | 12/02/1993SE |
| K925386 | Adhesive E.T. TapeCBH · Traditional | 04/19/1993SESK |
| K923690 | Mini HeartCAF · Traditional | 10/20/1992SE |
| K913015 | Heart Nebulizer Flowmeter AdaptorCAF · Traditional | 11/20/1991SE |
| K913753 | Bodai NEO2 -Safe Airway Pressure CapCAI · Traditional | 10/23/1991SE |
Questions and answers
When was Baby E.T. Tape(Tm) cleared by the FDA?
Baby E.T. Tape(Tm) (K871560) received a 510(k) decision of Substantially Equivalent on May 22, 1987, 30 days after the submission was received.
What is the product code of K871560?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.