FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
K Number: K851082
·
Decision Jul 22, 1985
Classifications
1
FEI Numbers
8
Registration Numbers
8
Same Product Code
1
Applicant Total
31
Review Days
126
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Basic Information
- Device Name
- V. MUELLER BLOM-SINGER ESOPHAGEAL INSUFFLATION TES
- K Number
- K851082
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 874.4175
- Medical Specialty
- Ear, Nose, Throat
- Decision
- Substantially Equivalent
- Applicant
- American V. Mueller
- Date Received
- March 18, 1985
- Decision Date
- July 22, 1985
- Product Code
- ENW
- 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 |
|---|---|---|---|
| ENW | Catheter, Nasopharyngeal | FDA class 1 | Ear, Nose, Throat |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ENW), ordered by most recent decision date.
View allOther Clearances by American V. Mueller
| K Number | Device Name | ||
|---|---|---|---|
| K873771 | HEYER-SCHULTE(R) ONE PIECE SHUNT VENT. CATH. INTRO | Dec 18, 1987 | Substantially Equivalent |
| K873332 | MAXIVAC(TM) CLOSED WOUND SUCTION DRAINAGE SYSTEM | Sep 8, 1987 | Substantially Equivalent |
| K871685 | HEYER-SCHULTE SPETZLER LUMBAR-PERITONEAL SHUNT SYS | Jun 12, 1987 | Substantially Equivalent |
| K864676 | HEYER-SCHULTE HERMETIC EXTERNAL CSF DRAIN. SYSTEM | Dec 29, 1986 | Substantially Equivalent |
| K862772 | V. MUELLER (R) GOOSENECK CIRCULAR STAPLER | Aug 18, 1986 | Substantially Equivalent |
| K861471 | V. MUELLER VITAL CLIP-HEMOSTATIC CLIP | Jun 6, 1986 | Substantially Equivalent |
| K854568 | V. MUELLER PNEUMO-INTESTINAL 15 VASCULAR & 30 STAP | Dec 2, 1985 | Substantially Equivalent |
| K854049 | HEYER-SCHULTE SYRINGO PERITONEAL SHUNT | Nov 27, 1985 | Substantially Equivalent |
| K851974 | V. MUELLER VITAL SKIN STAPLER | Jun 11, 1985 | Substantially Equivalent |
| K850947 | V-MUELLER INVERTED LINEAR ANASTOMOSIS INSTRUMENTS | Apr 17, 1985 | Substantially Equivalent |