FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
3M(TM) EAR IMPRESSION MATERIAL
K Number: K945726
·
Decision Jan 27, 1995
Classifications
1
FEI Numbers
101
Registration Numbers
101
Same Product Code
1366
Applicant Total
12
Review Days
66
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
- 3M(TM) EAR IMPRESSION MATERIAL
- K Number
- K945726
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.3300
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- 3M Medical Products Group
- Date Received
- November 22, 1994
- Decision Date
- January 27, 1995
- Product Code
- ESD
- Advisory Committee
- Ear, Nose, Throat
- Review Advisory Committee
- EN
- 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 |
|---|---|---|---|
| ESD | Hearing Aid, Air-Conduction, Prescription | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ESD), ordered by most recent decision date.
Lyric4 Hearing Aid
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC2
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
LYRIC HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
INSOUND XT SERIES HEARING AID
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
TCI COMBI (TINNITUS CONTROL INSTRUMENT COMBINATION)
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
SONIC INNOVATIONS COMPLETELY-IN-THE-CANAL DSP HEARING AID WITH SOFT SHELL
FDA 510(k)
FDA Class 1
·Ear, Nose, Throat
Other Clearances by 3M Medical Products Group
| K Number | Device Name | ||
|---|---|---|---|
| K971444 | 3M RED DOT 2234 & 2266 RADIOLUCENT MONITORING ELECTRODES | Jun 11, 1997 | Substantially Equivalent |
| K955103 | 3M NO STING BARRIER FILM | Feb 5, 1996 | Substantially Equivalent |
| K952121 | 3M RESIN CEMENT | Jun 22, 1995 | Substantially Equivalent |
| K941718 | 3M FLUID CONTROL SYSTEM 8300 CASSETTE LOAD | Oct 7, 1994 | Substantially Equivalent |
| K934333 | 3M RED DOT 2237 STICKY GEL MONITORING ECG ELECTRODE | Jul 7, 1994 | Substantially Equivalent |
| K923222 | 3M COLOR LASER IMAGER, MODEL 979 | Sep 30, 1992 | Substantially Equivalent |
| K923075 | 3M LASER IMAGER MODEL 969 | Sep 23, 1992 | Substantially Equivalent |
| K911252 | PRECISE BARND PI DISPOSABLE SURGICAL STAPLES | Jul 25, 1991 | Substantially Equivalent |
| K912225 | 3M DIGITAL RECORDING AUTOMATIC FILM HANDLING UNIT | Jul 22, 1991 | Substantially Equivalent |
| K910092 | 3M LASER IMAGER XL | Apr 8, 1991 | Substantially Equivalent |