LSP Minilator
FDA 510(k) K860516 · Life Support Products, Inc.
510(k) numberK860516
Submission
- Device name
- LSP Minilator
- Applicant
- Life Support Products, Inc.
Irvine, CA, US - Received
- February 11, 1986
- Decision date
- February 21, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BXY – Flowmeter, Calibration, Gas
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2350
- Specialty
- Anesthesiology
Other 510(k)s with product code BXY
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|---|---|---|---|
| K953506 | Westmed Respiratory Luer AdaptorBXY · Traditional | Westmed Intl. | 09/15/1995SE |
| K902917 | Precision Medical EliminatorBXY · Traditional | Precision Medical, Inc. | 07/23/1990SE |
| K902916 | Precision Medical Neb BlockBXY · Traditional | Precision Medical, Inc. | 07/23/1990SE |
| K863510 | Oxy-Off(Tm)BXY · Traditional | B&B Medical Technologies, Inc. | 10/22/1986SE |
| K851460 | New Connector & Cover for Telectronics 8MM UnipolaBXY · Traditional | Telectronics, Inc. | 05/10/1985SE |
| K781523 | PFT GasesBXY · Traditional | Gardner Cryogenics | 12/01/1978SE |
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| K940934 | Life VacBTA · Traditional | 05/03/1994SE |
| K936187 | Lspi Pressure RegulatorCAN · Traditional | 01/27/1994SE |
| K932200 | Lspi Automatic VentilatorBTL · Traditional | 11/24/1993SE |
| K932199 | Lspi Automatic Ventilator, Model AV3000BTL · Traditional | 11/24/1993SE |
| K922819 | Infant Disposable Bag Mask ResuscitatorBTM · Traditional | 11/24/1993SE |
| K922691 | LSP (Model 554) Bag Mask ResuscitatorBTM · Traditional | 11/24/1993SE |
| K921553 | Lspi Infant Bag MaskBTM · Traditional | 10/19/1992SE |
| K924217 | Lspi Disposable Bag Mask Resuscitator/ModifiedBTM · Traditional | 09/17/1992SE |
Questions and answers
When was LSP Minilator cleared by the FDA?
LSP Minilator (K860516) received a 510(k) decision of Substantially Equivalent on February 21, 1986, 10 days after the submission was received.
What is the product code of K860516?
The FDA product code is BXY – Flowmeter, Calibration, Gas, a Class I (low risk) device regulated under 21 CFR 868.2350.