FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ROBERTAZZI NASOPHARYNGEAL AIRWAY
K Number: K903618
·
Decision Jan 8, 1991
Classifications
1
FEI Numbers
122
Registration Numbers
122
Same Product Code
18
Applicant Total
13
Review Days
154
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ROBERTAZZI NASOPHARYNGEAL AIRWAY
- K Number
- K903618
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Eastmed Enterprises, Inc.
- Date Received
- August 7, 1990
- Decision Date
- January 8, 1991
- Product Code
- BTQ
- 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 |
|---|---|---|---|
| BTQ | Airway, Nasopharyngeal | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (BTQ), ordered by most recent decision date.
AD-TECH'S RAAB INFANT NASOPHARYNGEAL PRONGS
FDA 510(k)
FDA Class 1
·Anesthesiology
NASOPHARYNGEAL AIRWAY
FDA 510(k)
FDA Class 1
·Anesthesiology
NORTEC ROBERTAZZI NASOPHARYNGEAL AIRWAY
FDA 510(k)
FDA Class 1
·Anesthesiology
POLAMEDCO NASOPAHARYNGEAL AIRWAY
FDA 510(k)
FDA Class 1
·Anesthesiology
CHATHAM INDUSTRIES NASOPHARYNGEAL AIRWAY
FDA 510(k)
FDA Class 1
·Anesthesiology
SUNDERLAND NASAL TUBE
FDA 510(k)
FDA Class 1
·Anesthesiology
Other Clearances by Eastmed Enterprises, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K922019 | LARYNGOSCOPE RIGID | Jan 26, 1993 | Substantially Equivalent |
| K921128 | ENDOTRACHEAL TUBE STYLET | Jun 2, 1992 | Substantially Equivalent |
| K914741 | AMER PROFILE MILLER LARYNGOSCOPE BLADES, MODIFIED | Feb 3, 1992 | 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 |