Lspi Pressure Regulator
FDA 510(k) K936187 · Life Support Products, Inc.
510(k) numberK936187
Submission
- Device name
- Lspi Pressure Regulator
- Applicant
- Life Support Products, Inc.
Irvine, CA, US - Received
- December 23, 1993
- Decision date
- January 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CAN – Regulator, Pressure, Gas Cylinder
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.2700
- Specialty
- Anesthesiology
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More from Lifeguard Medical Products, Inc.
| 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 |
| 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 |
| K921107 | AutovacBTA · Traditional | 09/17/1992SE |
Questions and answers
When was Lspi Pressure Regulator cleared by the FDA?
Lspi Pressure Regulator (K936187) received a 510(k) decision of Substantially Equivalent on January 27, 1994, 35 days after the submission was received.
What is the product code of K936187?
The FDA product code is CAN – Regulator, Pressure, Gas Cylinder, a Class I (low risk) device regulated under 21 CFR 868.2700.