FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ECHO-OIL
K Number: K781631
·
Decision Oct 10, 1978
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
46
Applicant Total
4
Review Days
15
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
- ECHO-OIL
- K Number
- K781631
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4100
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- Echo Laboratories, Inc.
- Date Received
- September 25, 1978
- Decision Date
- October 10, 1978
- Product Code
- EMX
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| EMX | Balloon, Epistaxis | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EMX), ordered by most recent decision date.
PosiSep X BAM Hemostat Dressing/Intranasal Splint
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
NASALCEASE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
RAPID RHINO-ANTERIOR 90MM, MODEL RR-A 90, RAPID RHINO-POSTERIOR 100MM, MODEL RR-P 100
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HYLASINE
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
HYDROFERA BACTERISTATIC NASAL DRESSING
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
MEROGEL NASAL DRESSING AND SINUS STENT
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat