FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ENDOTRACHEAL TUBE STYLET
K Number: K921128
·
Decision Jun 2, 1992
Classifications
1
FEI Numbers
133
Registration Numbers
133
Same Product Code
31
Applicant Total
13
Review Days
84
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Basic Information
- Device Name
- ENDOTRACHEAL TUBE STYLET
- K Number
- K921128
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5790
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Eastmed Enterprises, Inc.
- Date Received
- March 10, 1992
- Decision Date
- June 2, 1992
- Product Code
- BSR
- 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 |
|---|---|---|---|
| BSR | Stylet, Tracheal Tube | FDA class 1 | Anesthesiology |
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MOLLOY INTUBATING STYLETTE
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RUSCH SCHROEDER ENDOTRACHEAL TUBE STYLE
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LIGHTED FLEXGUIDE (MODIFICATION)
FDA 510(k)
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Other Clearances by Eastmed Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922019 | LARYNGOSCOPE RIGID | Jan 26, 1993 | Substantially Equivalent |
| K914741 | AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED | Feb 3, 1992 | Substantially Equivalent |
| K903618 | ROBERTAZZI NASOPHARYNGEAL AIRWAY | Jan 8, 1991 | Substantially Equivalent |
| K901489 | MACINTOSH LARYNGOSCOPE BLADES (AMERICAN PROFILE) | Apr 10, 1990 | Substantially Equivalent |
| K890342 | AIRWAYS (GUEDEL, BERMAN & NASOPHARYNGEAL TYPES) | Apr 27, 1989 | Substantially Equivalent |
| K884584 | TONGUE SEIZING FORCEPS WITH & WITHOUT RUBBER PADS | Nov 14, 1988 | Substantially Equivalent |
| K884073 | LARYNGOSCOPE BLADE (ROBERTSHAW STYLE) | Oct 13, 1988 | Substantially Equivalent |
| K884072 | 15 MILLIMETER MALE AND FEMALE ADAPTERS | Oct 7, 1988 | Substantially Equivalent |
| K882433 | LARYNGOSCOPE RIGID | Sep 2, 1988 | Substantially Equivalent |
| K882434 | MASK, GAS, ANESTHETIC | Jun 30, 1988 | Substantially Equivalent |