Anesthesia Breathing Bags Sizes 1/2, 1,2,3 Liter
FDA 510(k) K894906 · Med-Tek Corp.
510(k) numberK894906
Submission
- Device name
- Anesthesia Breathing Bags Sizes 1/2, 1,2,3 Liter
- Applicant
- Med-Tek Corp.
Glendale, WI, US - Received
- August 1, 1989
- Decision date
- September 18, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| K940220 | Rebreather BagsBTC · Traditional | Zefon Medical Products | 05/27/1994SE |
| 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K903234 | F-19 Total Hip ProsthesisJDI · Traditional | 10/10/1990SE |
| K901687 | F-24 Femoral Hip ProsthesisLWJ · Traditional | 09/07/1990SE |
| K901451 | F-20 Cemented Metal-Backed Acetabular CupJDI · Traditional | 08/31/1990SN |
| K900428 | Anesthesia Breathing CircuitsCAI · Traditional | 08/17/1990SE |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | 08/14/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | 08/03/1990SE |
| K901480 | F-20 Total Hip ProsthesisJDI · Traditional | 06/12/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | 06/05/1990SE |
| K901272 | Orion Blade Plate for Tibial OsteotomyKTT · Traditional | 04/23/1990SE |
| K901240 | Astel Non-Metal Backed Acetabular Cup for CementedJDI · Traditional | 03/26/1990SE |
Questions and answers
When was Anesthesia Breathing Bags Sizes 1/2, 1,2,3 Liter cleared by the FDA?
Anesthesia Breathing Bags Sizes 1/2, 1,2,3 Liter (K894906) received a 510(k) decision of Substantially Equivalent on September 18, 1989, 48 days after the submission was received.
What is the product code of K894906?
The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.