Comfit Plus Endotracheal Tube Holder & Bite Block
FDA 510(k) K850309 · Ackrad Laboratories
510(k) numberK850309
Submission
- Device name
- Comfit Plus Endotracheal Tube Holder & Bite Block
- Applicant
- Ackrad Laboratories
Cranford, NJ, US - Received
- January 25, 1985
- Decision date
- February 14, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JAY – Support, Breathing Tube
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5280
- Specialty
- Anesthesiology
Other 510(k)s with product code JAY
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944988 | Custom Medical Suspension StrapJAY · Traditional | Custom Medical Specialties, Inc. | 01/27/1995SE |
| K873491 | Block, Bite, IntubationJAY · Traditional | B&B Medical Technologies, Inc. | 10/20/1987SE |
| K860583 | Dale Head Band Anesthesia Circuit Tube Holder 1315JAY · Traditional | Dale Medical Products, Inc. | 02/21/1986SE |
| K850924 | Jee Frame (Ventilator Circuit Support)JAY · Traditional | Vulcan Laboratories, Inc. | 07/19/1985SE |
| K840844 | Endo-SecureJAY · Traditional | Exidyne, Inc. | 03/16/1984SE |
| K834265 | Trach MateJAY · Traditional | Tempe Biomedical, Inc. | 01/04/1984SE |
| K834089 | ComfitJAY · Traditional | Ackrad Laboratories | 12/29/1983SE |
| K833374 | Bite-BlockJAY · Traditional | Sontek Industries, Inc. | 11/03/1983SE |
| K833361 | Tube-TitleJAY · Traditional | Sontek Industries, Inc. | 11/03/1983SE |
| K833332 | Schultz EndholdJAY · Traditional | Polyclinic Medical Center | 10/31/1983SE |
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Questions and answers
When was Comfit Plus Endotracheal Tube Holder & Bite Block cleared by the FDA?
Comfit Plus Endotracheal Tube Holder & Bite Block (K850309) received a 510(k) decision of Substantially Equivalent on February 14, 1985, 20 days after the submission was received.
What is the product code of K850309?
The FDA product code is JAY – Support, Breathing Tube, a Class I (low risk) device regulated under 21 CFR 868.5280.