Precision Med Products, Ltd. Breathing Bags
FDA 510(k) K932496 · Precision Med Products, Ltd.
510(k) numberK932496
Submission
- Device name
- Precision Med Products, Ltd. Breathing Bags
- Applicant
- Precision Med Products, Ltd.
Marrtinsville, IN, US - Received
- May 25, 1993
- Decision date
- July 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| 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 |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K932711 | Precision Med Products Ltd Guedel AirwaysBTR · Traditional | 07/23/1993SE |
| K932710 | Gas Sampling Lines and ConnectorsCAI · Traditional | 07/23/1993SE |
| K932709 | Precision Med Products Ltd Hyperinflation SystemBZR · Traditional | 07/23/1993SE |
| K932708 | Precision Med Products Ltd Mapleson D CircuitsCAI · Traditional | 07/23/1993SE |
| K932707 | Adult Anesthesia Breathing CircuitCAI · Traditional | 07/23/1993SE |
| K932706 | Precision Med Products Ltd. Ventilator HoseBZO · Traditional | 07/23/1993SE |
| K932712 | Precision Med Products Ltd Volume VentilatorsBZO · Traditional | 07/22/1993SE |
| K932497 | Precision Med Products, Ltd. Adult Gas SamplingCAI · Traditional | 07/22/1993SE |
| K932489 | PMP, Ltd. Adult Temp. Monitoring Anesthesia Cir.CAI · Traditional | 07/22/1993SE |
| K932488 | PMP, Ltd. Pediatric Gas Sampling CircuitsCAI · Traditional | 07/22/1993SE |
Questions and answers
When was Precision Med Products, Ltd. Breathing Bags cleared by the FDA?
Precision Med Products, Ltd. Breathing Bags (K932496) received a 510(k) decision of Substantially Equivalent on July 16, 1993, 52 days after the submission was received.
What is the product code of K932496?
The FDA product code is BTC – Bag, Reservoir, a Class I (low risk) device regulated under 21 CFR 868.5320.