Omnimed Nasal Oxygen Cannula
FDA 510(k) K850066 · Omni Intl., Inc.
510(k) numberK850066
Submission
- Device name
- Omnimed Nasal Oxygen Cannula
- Applicant
- Omni Intl., Inc.
Palm Springs, CA, US - Received
- January 8, 1985
- Decision date
- January 24, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAT – Cannula, Nasal, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5340
- Specialty
- Anesthesiology
Other 510(k)s with product code CAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional | Hudson Respiratory Care, Inc. | 06/13/2001SE |
| K935533 | Nasal CannulaCAT · Traditional | Puritas Health Care, Inc. | 02/03/1994SE |
| K922397 | 4 Sure TM Nasal Oxygen CannulaCAT · Traditional | Boston Pacific Medical, Inc. | 03/18/1993SE |
| K921496 | Skin Saver(Tm) Tubing Holder, Model 1921 ModifiedCAT · Traditional | Alpine Specialties, Inc. | 08/14/1992SE |
| K920573 | Cannula Nasal OxygenCAT · Traditional | B & F Medical Products, Inc. | 08/11/1992SE |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional | Specialty Packaging Producs, Inc. | 10/18/1991SE |
| K912197 | Skin Saver(Tm) Tubing Holder, Model 467CAT · Traditional | Alpine Specialties, Inc. | 08/20/1991SE |
| K911740 | Salter Labs Neonatal Nasal Oxygen CannulaCAT · Traditional | Salter Labs | 07/24/1991SE |
| K902420 | Catheter, Nasal, OxygenCAT · Traditional | Gainor Medical Europe, Ltd. | 04/17/1991SE |
| K896036 | The Comfortable CannulaCAT · Traditional | Comfortable Concepts Corp. | 11/17/1989SE |
More from Comfortable Concepts Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K984066 | Omnigrip, Latex Surgical Glove, Powder-Free with Protein Labeling ClaimKGO · Traditional | 01/13/1999SE |
| K984064 | Omnigrip, Latex Surgical Glove, Powder FreeKGO · Traditional | 01/08/1999SE |
| K853255 | Omnimed I.V. Solution Admin. SetFPA · Traditional | 08/23/1985SE |
| K851938 | Omnimed Surgical GownFYA · Traditional | 06/28/1985SE |
| K851654 | Omnimed ClampHXD · Traditional | 05/31/1985SE |
| K851734 | Omnimed Superior Transducer ProtectorFIB · Traditional | 05/23/1985SE |
| K850706 | F-Series ImplantDZE · Traditional | 04/10/1985SE |
| K850112 | Omnimed IV Solution Administration SetFPA · Traditional | 02/22/1985SE |
| K831147 | Omniprobe Electrical Nerve StimulatorGZJ · Traditional | 07/18/1983SE |
| K821523 | Omni TENSGZJ · Traditional | 06/16/1982SE |
Questions and answers
When was Omnimed Nasal Oxygen Cannula cleared by the FDA?
Omnimed Nasal Oxygen Cannula (K850066) received a 510(k) decision of Substantially Equivalent on January 24, 1985, 16 days after the submission was received.
What is the product code of K850066?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.