FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYOPACH ULTRASONIC PACHOMETER
K Number: K844112
·
Decision Jan 16, 1986
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
15
Review Days
450
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Basic Information
- Device Name
- MYOPACH ULTRASONIC PACHOMETER
- K Number
- K844112
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Applicant
- Myocure, Inc.
- Date Received
- October 23, 1984
- Decision Date
- January 16, 1986
- Product Code
- IYO
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Myocure, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K880347 | ANESTHESIA/RETROBULBAR NEEDLES | May 3, 1988 | Substantially Equivalent |
| K880346 | CANNULAS | May 3, 1988 | Substantially Equivalent |
| K880345 | CYSTOTOMES/KNIFES | May 3, 1988 | Substantially Equivalent |
| K874057 | OPHTHALMIC TIP & BLADE SCALPELS | Dec 23, 1987 | Substantially Equivalent |
| K874056 | OPHTHALMIC DISPOSABLE BLADES | Dec 22, 1987 | Substantially Equivalent |
| K873385 | OPHTHALMIC PHACO-BLADE | Sep 21, 1987 | Substantially Equivalent |
| K864371 | SURGICAL SKIN MARKER | Nov 17, 1986 | Substantially Equivalent |
| K863666 | THE SAVER KIT | Oct 20, 1986 | Substantially Equivalent |
| K863663 | OPHTHALMIC SURGICAL OCULAR MARKERS | Oct 20, 1986 | Substantially Equivalent |
| K863662 | OPHTHALMIC SURGICAL DRAPE | Oct 20, 1986 | Substantially Equivalent |