PLM Sensor, Model PLM1
FDA 510(k) K940014 · Pro-Tech, Inc.
510(k) numberK940014
Submission
- Device name
- PLM Sensor, Model PLM1
- Applicant
- Pro-Tech, Inc.
Woodinville, WA, US - Received
- January 4, 1994
- Decision date
- November 10, 1994
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZQ – Monitor, Breathing Frequency
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.2375
- Specialty
- Anesthesiology
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|---|---|---|
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| K913396 | Cannula Style ThermocouplesBZG · Traditional | 05/22/1992SE |
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Questions and answers
When was PLM Sensor, Model PLM1 cleared by the FDA?
PLM Sensor, Model PLM1 (K940014) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on November 10, 1994, 310 days after the submission was received.
What is the product code of K940014?
The FDA product code is BZQ – Monitor, Breathing Frequency, a Class II (moderate risk) device regulated under 21 CFR 868.2375.