FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
MASK, GAS, ANESTHETIC
K Number: K882434
·
Decision Jun 30, 1988
Classifications
1
FEI Numbers
158
Registration Numbers
158
Same Product Code
50
Applicant Total
13
Review Days
16
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Basic Information
- Device Name
- MASK, GAS, ANESTHETIC
- K Number
- K882434
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5550
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Eastmed Enterprises, Inc.
- Date Received
- June 14, 1988
- Decision Date
- June 30, 1988
- Product Code
- BSJ
- 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 |
|---|---|---|---|
| BSJ | Mask, Gas, Anesthetic | FDA class 1 | Anesthesiology |
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| 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 |