Rebreather Bags
FDA 510(k) K940220 · Zefon Medical Products
510(k) numberK940220
Submission
- Device name
- Rebreather Bags
- Applicant
- Zefon Medical Products
Ocala, FL, US - Received
- January 21, 1994
- Decision date
- May 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTC – Bag, Reservoir
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5320
- Specialty
- Anesthesiology
Other 510(k)s with product code BTC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K181424 | PeDIABTC · Traditional | Pedia, LLC | 09/25/2018SE |
| K932584 | Breathing BagsBTC · Traditional | Merit Medical Systems, Inc. | 07/16/1993SE |
| K932581 | Breathing BagsBTC · Traditional | Med-Plastics Intl., Inc. | 07/16/1993SE |
| K932496 | Precision Med Products, Ltd. Breathing BagsBTC · Traditional | Precision Med Products, Ltd. | 07/16/1993SE |
| K932191 | Breathing BagsBTC · Traditional | Life Shield Healthcare Products, Inc. | 07/02/1993SE |
| K894906 | Anesthesia Breathing Bags Sizes 1/2, 1,2,3 LiterBTC · Traditional | Med-Tek Corp. | 09/18/1989SE |
| K880680 | King Systems, Breathing BagBTC · Traditional | King Systems Corp. | 03/03/1988SE |
| K864822 | Varidyne 550, Models 12E,12M,24E & 24M Suction SysBTC · Traditional | Surgidyne, Inc. | 01/15/1987SE |
| K841412 | Rolled Neck W/TapBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
| K841411 | Rolled Neck W/PlugBTC · Traditional | Warne Surgical Products, Ltd. | 04/18/1984SE |
More from Warne Surgical Products, Ltd.
Questions and answers
When was Rebreather Bags cleared by the FDA?
Rebreather Bags (K940220) received a 510(k) decision of Substantially Equivalent on May 27, 1994, 126 days after the submission was received.
What is the product code of K940220?
The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.