Oxygen Tubing
FDA 510(k) K840897 · Medical Technologies of Georgia
510(k) numberK840897
Submission
- Device name
- Oxygen Tubing
- Applicant
- Medical Technologies of Georgia
Mchenry, IL, US - Received
- February 27, 1984
- Decision date
- March 16, 1984
- 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 |
|---|---|---|
| K080878 | MTG Instant Cather (with and Without Kit), MTG Instant Cath Deluxe (with and Without Kit)KOD · Traditional | 07/17/2008SE |
| K973120 | Readycath CatheterGBM · Traditional | 02/25/1998SE |
| K952392 | Mli SetFPA · Traditional | 08/07/1995SE |
| K911129 | MMG Bile BagEXF · Traditional | 08/07/1991SE |
| K873136 | MMG Cath-N-PlaceKNX · Traditional | 09/09/1987SE |
| K871949 | MMG Delee Suction Catheter W/Mucous TrapBSY · Traditional | 06/15/1987SE |
| K854821 | MMG External Female CathetersKNX · Traditional | 04/24/1986SE |
| K854660 | The MMG Enteral Feeding Administration SetKNT · Traditional | 01/21/1986SE |
| K840839 | MMG Foley CatheterKOD · Traditional | 04/17/1984SE |
| K821854 | U-200 BagKNX · Traditional | 07/22/1982SE |
Questions and answers
When was Oxygen Tubing cleared by the FDA?
Oxygen Tubing (K840897) received a 510(k) decision of Substantially Equivalent on March 16, 1984, 18 days after the submission was received.
What is the product code of K840897?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.