49-610 Niko-Nose Fixation Tape
FDA 510(k) K902896 · Nikomed U.S.A., Inc.
510(k) numberK902896
Submission
- Device name
- 49-610 Niko-Nose Fixation Tape
- Applicant
- Nikomed U.S.A., Inc.
North Brunswick, NJ, US - Received
- July 3, 1990
- Decision date
- October 23, 1990
- 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 |
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| 510(k) | Device | Decision |
|---|---|---|
| K022909 | Nikomed Trace 1 ECG ElectrodesDRX · Special | 01/09/2003SE |
| K000079 | Nikopad Electrosurgical Grounding Pad, Model 4777MHAM · Special | 02/04/2000SE |
| K950473 | Disposable ECG Monitoring ElectrodeDRX · Traditional | 12/12/1995SE |
| K950475 | Disposable ECG Monitoring Electrode #4530, #4540DRX · Traditional | 11/14/1995SE |
| K950472 | Disposable ECG Monitoring Electrode #4110 45MM, #4140 35MMDRX · Traditional | 11/14/1995SE |
| K950480 | Disposable ECG Monitoring Electrode #4539 28X45MMDRX · Traditional | 11/06/1995SE |
| K950478 | Disposable ECG Monitoring Electrode #4570 38X60MMDRX · Traditional | 11/06/1995SE |
| K950477 | Disposable ECG Monitoring Electrode #4560 38X60MMDRX · Traditional | 11/06/1995SE |
| K950474 | Disposable ECG Monitoring Electrode #4533 32X45MMDRX · Traditional | 11/06/1995SE |
| K950471 | Disposable ECG Monitoring Electrode #4580 32X45MMDRX · Traditional | 11/06/1995SE |
Questions and answers
When was 49-610 Niko-Nose Fixation Tape cleared by the FDA?
49-610 Niko-Nose Fixation Tape (K902896) received a 510(k) decision of Substantially Equivalent on October 23, 1990, 112 days after the submission was received.
What is the product code of K902896?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.