Spiritus(Tm) Respiratory System #Srs 001
FDA 510(k) K020641 · Worldwide Medical Technologies, LLC
510(k) numberK020641
Submission
- Device name
- Spiritus(Tm) Respiratory System #Srs 001
- Applicant
- Worldwide Medical Technologies, LLC
Waycross, GA, US - Received
- February 27, 2002
- Decision date
- October 29, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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Questions and answers
When was Spiritus(Tm) Respiratory System #Srs 001 cleared by the FDA?
Spiritus(Tm) Respiratory System #Srs 001 (K020641) received a 510(k) decision of Substantially Equivalent on October 29, 2002, 244 days after the submission was received.
What is the product code of K020641?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.