Augustine Intubation Guide
FDA 510(k) K954446 · Augustine Medical, Inc.
510(k) numberK954446
Submission
- Device name
- Augustine Intubation Guide
- Applicant
- Augustine Medical, Inc.
Eden Prairie, MN, US - Received
- September 25, 1995
- Decision date
- December 29, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CCW – Laryngoscope, Rigid
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5540
- Specialty
- Anesthesiology
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| K963293 | Augustine Medical Wound Care System Model 68XXXMSA · Traditional | 03/28/1997SN |
| K963672 | Model 90022 Rolling StandJOW · Traditional | 01/06/1997SE |
| K960167 | System, Thermal Regulating 74-DWJDWJ · Traditional | 06/17/1996SE |
| K952864 | Bair Hugger Model 655 BlanketDWJ · Traditional | 09/12/1995SE |
| K950416 | Bair Hugger Model 600 Unit, BlanketsDWJ · Traditional | 08/29/1995SE |
Questions and answers
When was Augustine Intubation Guide cleared by the FDA?
Augustine Intubation Guide (K954446) received a 510(k) decision of Substantially Equivalent on December 29, 1995, 95 days after the submission was received.
What is the product code of K954446?
The FDA product code is CCW – Laryngoscope, Rigid, a Class I (low risk) device regulated under 21 CFR 868.5540.