LSP Automatic Ventilator, Model 456
FDA 510(k) K870424 · Life Support Products, Inc.
510(k) numberK870424
Submission
- Device name
- LSP Automatic Ventilator, Model 456
- Applicant
- Life Support Products, Inc.
Irvine, CA, US - Received
- February 3, 1987
- Decision date
- January 22, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BTL – Ventilator, Emergency, Powered (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5925
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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| K161420 | Moves SLCBTL · Traditional | Thornhill Research, Inc. | 06/06/2017SE |
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| K141595 | O-Two E700,O-TWO E600,O-TWO E500BTL · Traditional | O-Two Medical Technologies, Inc. | 03/16/2015SE |
| K142096 | T-Piece ResuscitatorBTL · Traditional | Mercury Medical | 10/17/2014SE |
More from Mercury Medical
| 510(k) | Device | Decision |
|---|---|---|
| K941871 | Lspi Automatic Ventilator, Model AV3000-100BTL · Traditional | 01/09/1995SE |
| K941870 | Lspi Automatic Ventilator, Model AV2000-100BTL · Traditional | 01/09/1995SE |
| 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 Automatic Ventilator, Model 456 cleared by the FDA?
LSP Automatic Ventilator, Model 456 (K870424) received a 510(k) decision of Substantially Equivalent on January 22, 1988, 353 days after the submission was received.
What is the product code of K870424?
The FDA product code is BTL – Ventilator, Emergency, Powered (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5925.