Startrack Infant Graphics Monitor
FDA 510(k) K983274 · Nellcor Puritan Bennett, Inc.
510(k) numberK983274
Submission
- Device name
- Startrack Infant Graphics Monitor
- Applicant
- Nellcor Puritan Bennett, Inc.
Lenexa, KS, US - Received
- September 17, 1998
- Decision date
- December 9, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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Questions and answers
When was Startrack Infant Graphics Monitor cleared by the FDA?
Startrack Infant Graphics Monitor (K983274) received a 510(k) decision of Substantially Equivalent on December 9, 1998, 83 days after the submission was received.
What is the product code of K983274?
The FDA product code is BZK – Spirometer, Monitoring (W/Wo Alarm), a Class II (moderate risk) device regulated under 21 CFR 868.1850.