Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,In-Line Specimen Trap
FDA 510(k) K972139 · Davis & Geck, Inc.
510(k) numberK972139
Submission
- Device name
- Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,In-Line Specimen Trap
- Applicant
- Davis & Geck, Inc.
Hazlewood, MO, US - Received
- June 6, 1997
- Decision date
- September 3, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTM – Ventilator, Emergency, Manual (Resuscitator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5915
- Specialty
- Anesthesiology
- Life-sustaining
- Yes
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Questions and answers
When was Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,In-Line Specimen Trap cleared by the FDA?
Aspr-Care Closed System,Dual Swivel Piece T,Sheathed Suction Catheter,Bronchosope Adapter,In-Line Specimen Trap (K972139) received a 510(k) decision of Substantially Equivalent on September 3, 1997, 89 days after the submission was received.
What is the product code of K972139?
The FDA product code is BTM – Ventilator, Emergency, Manual (Resuscitator), a Class II (moderate risk) device regulated under 21 CFR 868.5915.