LPA-3 Printer
FDA 510(k) K851805 · Life Products, Inc.
510(k) numberK851805
Submission
- Device name
- LPA-3 Printer
- Applicant
- Life Products, Inc.
Boulder, CO, US - Received
- April 30, 1985
- Decision date
- July 8, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZC – Calculator, Pulmonary Function Data
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1880
- Specialty
- Anesthesiology
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| K901714 | Lifestyle Home Tanning UnitsLEJ · Traditional | 06/27/1990SE |
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| K851905 | LPA-2 Remote AlarmCAP · Traditional | 07/08/1985SE |
| K844179 | LP-5CBK · Traditional | 01/18/1985SE |
| K842122 | 4ACBK · Traditional | 01/18/1985SE |
| K844081 | LP4 VentilatorCBK · Traditional | 01/16/1985SE |
| K844290 | L100D Patient Circuit Dual LineBZO · Traditional | 01/10/1985SE |
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Questions and answers
When was LPA-3 Printer cleared by the FDA?
LPA-3 Printer (K851805) received a 510(k) decision of Substantially Equivalent on July 8, 1985, 69 days after the submission was received.
What is the product code of K851805?
The FDA product code is BZC – Calculator, Pulmonary Function Data, a Class II (moderate risk) device regulated under 21 CFR 868.1880.