FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
RORERTAZZI NASOPHARYNGEAL AIRWAY
K Number: K873949
·
Decision Oct 20, 1987
Classifications
1
FEI Numbers
127
Registration Numbers
127
Same Product Code
18
Applicant Total
8
Review Days
22
Basic Information
- Device Name
- RORERTAZZI NASOPHARYNGEAL AIRWAY
- K Number
- K873949
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5100
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- PENN MEDICAL DEVICES, INC.
- Date Received
- September 28, 1987
- Decision Date
- October 20, 1987
- 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 |
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Other Clearances by PENN MEDICAL DEVICES, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K873177 | DEVINE (SUPRAPUBIC SOUND AND GUIDE) | Oct 14, 1987 | Substantially Equivalent |
| K873176 | HUFFMAN BIOPSY UNIT | Oct 14, 1987 | Substantially Equivalent |
| K873178 | URETERAL BULB DILATORS | Sep 30, 1987 | Substantially Equivalent |
| K871667 | URETERAL STENT | Jun 10, 1987 | Substantially Equivalent |
| K870508 | GASTROINTESTINAL TUBE | May 11, 1987 | Substantially Equivalent |
| K862729 | PENN 3-RING HANDLE | Oct 24, 1986 | Substantially Equivalent |
| K862107 | PENN & OLYMPUS URETEROSCOPY GUIDE SHEATH & DILATOR | Sep 11, 1986 | Substantially Equivalent |