FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HOLTER SCREENING MONITOR HS-221
K Number: K842462
·
Decision Sep 11, 1984
Classifications
1
FEI Numbers
103
Registration Numbers
103
Same Product Code
338
Applicant Total
17
Review Days
81
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Basic Information
- Device Name
- HOLTER SCREENING MONITOR HS-221
- K Number
- K842462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2300
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Advantage Medical Systems, Inc.
- Date Received
- June 22, 1984
- Decision Date
- September 11, 1984
- Product Code
- DRT
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DRT | Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | FDA class 2 | Cardiovascular |
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Other Clearances by Advantage Medical Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K873957 | NON-CORING HUBER TYPE NEEDLES | Oct 23, 1987 | Substantially Equivalent |
| K873290 | LACERATION AND INSTRUMENT TRAYS | Sep 24, 1987 | Substantially Equivalent |
| K863494 | NEONATAL PHYSIOLOGICAL MONITOR MODEL PM 20 | Dec 22, 1986 | Substantially Equivalent |
| K861556 | MODIFIED FETAL MONITOR MODEL FM-2 | Jul 7, 1986 | Substantially Equivalent |
| K861279 | FLUORO PLUS | Jun 16, 1986 | Substantially Equivalent |
| K861455 | MODEL DT-102 DATA TELEPHONE TRANSMITTER | May 30, 1986 | Substantially Equivalent for Some Indications |
| K852518 | MODIFICATION FETAL MONITOR MODEL FM-2 | Jul 5, 1985 | Substantially Equivalent |
| K844724 | FETAL TELEMETRY SYSTEM | May 1, 1985 | Substantially Equivalent |
| K840747 | TOCO DATA TELEPHONE TRANSMITTER DT100P | Jun 19, 1984 | Substantially Equivalent |
| K832849 | FETAL MONITOR #FM-2 | Oct 4, 1983 | Substantially Equivalent |