Et-Restraint Cat. # Er 4000
FDA 510(k) K900236 · Ventlab Corp.
510(k) numberK900236
Submission
- Device name
- Et-Restraint Cat. # Er 4000
- Applicant
- Ventlab Corp.
Hackensack, NJ, US - Received
- January 17, 1990
- Decision date
- February 2, 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 |
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| K102674 | Cuff SentryBSK · Traditional | 07/22/2011SE |
| K093617 | Ventlab 6000 Series HumidifierBTT · Traditional | 01/27/2011SE |
| K093525 | Ace/Statcheck II CO2 Indicator, Ace/Statcheck II CO2 Indicator Arm Assemby Adult…CCK · Special | 12/10/2009SE |
| K090840 | Ventlab 5000 Series Nebulizer Assembly, Cup, Cup W/ Mask, Cup W/ Fitsall Conn.CAF · Traditional | 06/25/2009SE |
| K082204 | Series Sy Disposable Electrosurgical PadODR · Traditional | 08/13/2008SE |
| K063813 | Ventlab Nasal CO2 SAMPLING/O2 Delivery CannulaCCK · Traditional | 03/26/2008SE |
| K040726 | Ventlab Nasal CPAP CannulaBZD · Traditional | 06/03/2004SE |
| K030271 | Ventlab Bacterial Filter, Model BF100CAH · Traditional | 07/07/2003SE |
Questions and answers
When was Et-Restraint Cat. # Er 4000 cleared by the FDA?
Et-Restraint Cat. # Er 4000 (K900236) received a 510(k) decision of Substantially Equivalent on February 2, 1990, 16 days after the submission was received.
What is the product code of K900236?
The FDA product code is CBH – Device, Fixation, Tracheal Tube, a Class I (low risk) device regulated under 21 CFR 868.5770.