FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OROTRACHEAL INTUBATION ENDOSCOPE
K Number: K801452
·
Decision Jul 14, 1980
Classifications
1
FEI Numbers
315
Registration Numbers
315
Same Product Code
63
Applicant Total
142
Review Days
21
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Basic Information
- Device Name
- OROTRACHEAL INTUBATION ENDOSCOPE
- K Number
- K801452
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5540
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Olympus Corp.
- Date Received
- June 23, 1980
- Decision Date
- July 14, 1980
- Product Code
- CCW
- 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 |
|---|---|---|---|
| CCW | Laryngoscope, Rigid | FDA class 1 | Anesthesiology |
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Other Clearances by Olympus Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K915402 | EW-10 AND EW-20 | Jun 23, 1995 | Substantially Equivalent for Some Indications |
| K933200 | OLYMPUS PBD STENTS | Apr 5, 1995 | Substantially Equivalent |
| K942338 | OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES | Nov 30, 1994 | Substantially Equivalent |
| K931763 | HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS | Aug 29, 1994 | Substantially Equivalent |
| K934835 | FLOVAL | Jun 21, 1994 | Substantially Equivalent |
| K931764 | HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES | Jun 8, 1994 | Substantially Equivalent |
| K915857 | FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE | Mar 11, 1994 | Substantially Equivalent |
| K931994 | RESECTOSCOPE SHEATH | Feb 17, 1994 | Substantially Equivalent |
| K933992 | OLYMPUS SCLEROTHERAPY BALLOON | Dec 21, 1993 | Substantially Equivalent |
| K934361 | OLYMPUS CREATININE REAGENT | Nov 16, 1993 | Substantially Equivalent |