FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAS SAMPLING INTERFACES
K Number: K943110
·
Decision Aug 19, 1994
Classifications
1
FEI Numbers
230
Registration Numbers
230
Same Product Code
61
Applicant Total
5
Review Days
51
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Basic Information
- Device Name
- GAS SAMPLING INTERFACES
- K Number
- K943110
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5860
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Coast Medical, Inc.
- Date Received
- June 29, 1994
- Decision Date
- August 19, 1994
- Product Code
- BYX
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| BYX | Tubing, Pressure And Accessories | FDA class 1 | Anesthesiology |
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Other Clearances by Coast Medical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K952243 | EXTENSION SET/I.V. SET | Jul 26, 1995 | Substantially Equivalent |
| K944729 | STYLET SHEATH WITH LOCKING CAP AND REUSABLE BATTERY OPERATED LIGHT SOURCE | Dec 21, 1994 | Substantially Equivalent |
| K943270 | SURFACE TEMPERATURE PROBES | Dec 5, 1994 | Substantially Equivalent |
| K943495 | DISPOSABLE ESOPHAGEAL STETHOSCOPE | Sep 8, 1994 | Substantially Equivalent |