N-D0-SURE
FDA 510(k) K811185 · Ackrad Laboratories
510(k) numberK811185
Submission
- Device name
- N-D0-SURE
- Applicant
- Ackrad Laboratories
Mchenry, IL, US - Received
- April 29, 1981
- Decision date
- June 2, 1981
- 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 |
|---|---|---|
| K021272 | Sib Catheter, Model 61-7005LKF · Special | 05/21/2002SE |
| K020954 | H/S Procedure Tray (5F), H/S Procedure Tray (7F), H/S Elliptosphere Procedure Tray &…LKF · Special | 04/24/2002SE |
| K020951 | H/S Catheter Set (5F), Model 61-5005; H/S Catheter Set (7F), Model 61-5007LKF · Special | 04/16/2002SE |
| K970492 | Intrauterine Insemination and Sonohysterography CatheterLKF · Traditional | 04/09/1997SE |
| K961752 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/08/1996SE |
| K952542 | Ackrad Esophageal Balloon Catheter SetBZC · Traditional | 04/23/1996SE |
| K940176 | Ackrad Iui Set for Intrauterine InseminationMFD · Traditional | 04/23/1996SE |
| K953034 | H/S Catheter SET(61-3005, 61-3007, 61-3605, 61-3607)LKF · Traditional | 08/29/1995SE |
| K915813 | Ackrad Ercp Contrast Delivery SetFGE · Traditional | 03/11/1992SE |
| K904499 | Nicos (Non-Invasive Cardiac Output System)KFG · Traditional | 07/01/1991SE |
Questions and answers
When was N-D0-SURE cleared by the FDA?
N-D0-SURE (K811185) received a 510(k) decision of Substantially Equivalent on June 2, 1981, 34 days after the submission was received.
What is the product code of K811185?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.