RMS 111F Respiratory Monitoring System
FDA 510(k) K800086 · The Perkin-Elmer Corp.
510(k) numberK800086
Submission
- Device name
- RMS 111F Respiratory Monitoring System
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- January 14, 1980
- Decision date
- May 8, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- BZK – Spirometer, Monitoring (W/Wo Alarm)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1850
- Specialty
- Anesthesiology
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| K103578 | Philips NM3 Respiratory Monitor with VentassistBZK · Traditional | Respironics Novametrix, LLC | 06/02/2011SE |
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| K092217 | Mercury VCO2BZK · Special | Respironics Novametrix, Inc. | 08/21/2009SE |
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Questions and answers
When was RMS 111F Respiratory Monitoring System cleared by the FDA?
RMS 111F Respiratory Monitoring System (K800086) received a 510(k) decision of Substantially Equivalent on May 8, 1980, 115 days after the submission was received.
What is the product code of K800086?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.