Oxygen Enrichment Kit, Models SG 066, SG 067
FDA 510(k) K992670 · Instrumentation Industries, Inc.
510(k) numberK992670
Submission
- Device name
- Oxygen Enrichment Kit, Models SG 066, SG 067
- Applicant
- Instrumentation Industries, Inc.
Bethel Park, PA, US - Received
- June 21, 1999
- Decision date
- September 17, 1999
- Decision
- Substantially Equivalent - Subject to Tracking Reg. (ST)
- Type
- Traditional 510(k)
Device classification
- Product code
- CBK – Ventilator, Continuous, Facility Use
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5895
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Oxygen Enrichment Kit, Models SG 066, SG 067 cleared by the FDA?
Oxygen Enrichment Kit, Models SG 066, SG 067 (K992670) received a 510(k) decision of Substantially Equivalent - Subject to Tracking Reg. on September 17, 1999, 88 days after the submission was received.
What is the product code of K992670?
The FDA product code is CBK – Ventilator, Continuous, Facility Use, a Class II (moderate risk) device regulated under 21 CFR 868.5895.