Monitors, Remote, RMS III
FDA 510(k) K770721 · The Perkin-Elmer Corp.
510(k) numberK770721
Submission
- Device name
- Monitors, Remote, RMS III
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- April 18, 1977
- Decision date
- April 28, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1400
- Specialty
- Anesthesiology
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Questions and answers
When was Monitors, Remote, RMS III cleared by the FDA?
Monitors, Remote, RMS III (K770721) received a 510(k) decision of Substantially Equivalent on April 28, 1977, 10 days after the submission was received.
What is the product code of K770721?
The FDA product code is CCK – Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase, a Class II (moderate risk) device regulated under 21 CFR 868.1400.